MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2014-04-17 for T4 - THYROXINE 12017709122 manufactured by Roche Diagnostics.
[4468540]
The customer received questionable results for thyroxine (t4) on three patient samples. The results were questioned by physicians, and the samples were sent to other sites for testing. One of the three samples was run on this instrument, one sample the customer could not clarify which instrument generated the results, and one sample was repeated on this cobas 6000 e601 analyzer. All results are in ug/dl. Patient 1 was reported outside of the laboratory on (b)(6) 2014 as 19. 6 from this instrument. It was repeated on (b)(6) 2014 on this instrument and generated a result of 19. 8. The sample was run on a siemens centaur and generated a result of 8. 4. The sample was also run at a reference laboratory and generated a result of 8. 9 on what the customer believes to be a beckman system. Patient 2 was reported outside of the laboratory on (b)(6) 2014 as 20. 1, which was generated on another cobas 6000 e601 (e601). The sample was repeated on this e601 and generated a result of 21. 5. The sample was run on a siemens centaur and generated a result of 10. 6. The sample was also run at a reference laboratory and generated a result of 9. 3 on what the customer believes to be a beckman system. Patient 3 was reported outside of the laboratory as 21. 7, the date of the report and the instrument it was run on is not known by the customer. The sample was run on a siemens centaur and generated a result of 15. 4. The sample was sent to a different reference laboratory and generated a result of 18. 2. The methodology at the different reference laboratory was unknown to the customer. The customer deemed the results from the other methodologies to be correct for all the samples. There was no adverse event for any of the patients. The serial number of the e601 used in this case was (b)(4). The field service representative could not find a cause and could not duplicate the error. He cleaned the prewash sipper line, checked the reagent and sample syringe, and liquid level detection voltage. He ran a mechanical check and verified all related parts were functioning normally. He performed a precision check. The customer performed testing and qc, which were within specification. For the medwatch for the erroneous results generated on e601 with serial number (b)(4), please see medwatch with patient identifier (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[4551151]
Patient 1 was reported outside of the laboratory on (b)(6) 2014 with a t4 of 19. 61 ug/ml. The sample was repeated on this instrument and generated a result of 19. 84 ug/ml, which was after the sample was treated with "scantibody colum". The patient also had a t4 result on an "850" of 19. 8 ug/ml. The t4 result of 8. 9 ug/dl was generated on a beckman system. Patient 1 also had a thyrotropin (tsh) result of 0. 435 uiu/ml and a t- uptake (t-up) result of <0. 2 tbi on an "850". The sample was repeated on this instrument and generated a tsh of 0. 43 uiu/ml and a t-up of <0. 2 tbi. The sample was repeated on this instrument after the sample was treated with "scantibody colum" and generated a tsh result of 0. 362 uiu/ml, and a t-up result of <0. 2 tbi. The sample was then sent to a reference laboratory and run on a siemens instrument and generated a tsh result of 0. 599 uiu/ml, and a t-up result of 32. 1%. It is unknown which result the customer deemed to be correct and if there was an adverse event.
Patient Sequence No: 1, Text Type: D, B5
[11721618]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[11769928]
The initial and repeat results for t4 have been corrected below for patient 1. Patient 1 was reported outside of the laboratory on (b)(6) 2014 with a t4 of 19. 61 ug/ml. The sample was repeated on this instrument and generated a result of 19. 84 ug/ml. The information below is new information for patient 1. The repeat t4 result of 19. 84 ug/ml was generated after the sample was treated with "scantibody colum". The patient also had a t4 result on an "850" of 19. 8 ug/ml. The t4 result of 8. 9 ug/dl was generated on a beckman system. Patient 1 also had a thyrotropin (tsh) result of 0. 435 uiu/ml and a t- uptake (t-up) result of <0. 2 tbi on an "850". The sample was repeated on this instrument and generated a tsh of 0. 43 uiu/ml and a t-up of <0. 2 tbi. The sample was repeated on this instrument after the sample was treated with "scantibody colum" and generated a tsh result of 0. 362 uiu/ml, and a t-up result of <0. 2 tbi. The sample was then sent to a reference laboratory and run on a siemens instrument and generated a tsh result of 0. 599 uiu/ml, and a t-up result of 32. 1%. It is unknown which result the customer deemed to be correct and if there was an adverse event.
Patient Sequence No: 1, Text Type: N, H10
[11787957]
Patient 2 returned on (b)(6) 2014 and had a new sample drawn, which generated erroneous t4 results. The sample was initially tested at a sister facility on an e411 and gave a result of 21. 7 ug/dl. Refer to medwatch 1823260-2014-03479 for the med watch report for the sister facility, e411. The sample was then sent to this laboratory and run on the cobas 6000 e601 (e601) serial number (b)(4) and generated a result of 20. 0 ug/dl. The sample was then sent to another laboratory and was run on a siemens instrument and the result was 12. 7 ug/dl. The result of 21. 7 ug/dl was reported to the physician, but the physician was informed there was an investigation into a potential interference. The customer deems the other methodology to be correct. There has been no adverse impact to the patient. The sample from (b)(6) 2014 has been requested for further investigation.
Patient Sequence No: 1, Text Type: N, H10
[11828995]
On further follow up with the customer, it was determined that the t-up results of <0. 2 tbi were accompanied by data flags. The customer also indicated that "850" is a designation for their satellite laboratory. This satellite laboratory has a roche analyzer for immunoassays. The customer was not certain if the instrument was an e601 or a cobas e 411 (e411) instrument.
Patient Sequence No: 1, Text Type: N, H10
[11830908]
The investigation could not determine a specific root cause. The samples are not available for investigation. Additional information was requested for investigation, but could not be provided by the customer. Performance data for the reagent was reviewed and within specification. A general reagent issue can be excluded.
Patient Sequence No: 1, Text Type: N, H10
[11939671]
Additional testing was performed during the investigation on the sample for patient 2: anti-tg: 58. 02 iu/ml anti-tpo: 86. 69 iu/ml.
Patient Sequence No: 1, Text Type: N, H10
[12015886]
On follow up with the customer, they indicated that patient 2 is taking a vitamin d supplement and birth control pills. The patient also had additional thyroid results that were generated on the e411 at the customer's sister laboratory on (b)(6) 2014. The patient had a "t3" result of 184 ng/dl, a "t-uptake" result of 1. 5 tbi, a "tsh" result of 0. 263 uiu/ml and a "t4, free" result of 1. 5 ng/dl.
Patient Sequence No: 1, Text Type: N, H10
[21580016]
The investigation determined that no interfering factors seemed to be present in the investigated sample. It was also determined that no interference from pharmaceuticals seemed to be present either. A general reagent issue was excluded. The difference between the elecsys and other assays could possibly be attributed to differences in methods and instruments, differences in standardization and applications and different antibodies.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2014-02769 |
| MDR Report Key | 3756084 |
| Report Source | 05,06,07 |
| Date Received | 2014-04-17 |
| Date of Report | 2014-07-28 |
| Date of Event | 2014-03-13 |
| Date Mfgr Received | 2014-03-26 |
| Date Added to Maude | 2014-04-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | T4 - THYROXINE |
| Generic Name | RADIOIMMUNOASSAY, TOTAL THYROXINE |
| Product Code | CDX |
| Date Received | 2014-04-17 |
| Model Number | NA |
| Catalog Number | 12017709122 |
| Lot Number | 17416501 |
| ID Number | NA |
| Device Expiration Date | 2015-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-17 |