MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-04-20 for T4 12017709122 manufactured by Roche Diagnostics.
[43019831]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[43019832]
The customer reported that they received erroneous results for two samples from the same patient tested for thyrotropin (tsh), free triiodothyronine (ft3), free thyroxine (ft4), triiodothyronine (t3), and thyroxine (t4) on an e601 analyzer. The e601 results were different when compared to the results from an advia centaur analyzer. It was asked, but it is not known if any erroneous results were reported outside of the laboratory. This medwatch will cover t4. Please refer to the medwatch with patient identifier (b)(6) for information related to t3, refer to the medwatch with patient identifier (b)(6) for information related to tsh, refer to the medwatch with patient identifier (b)(6) for information related to ft3, refer to the medwatch with patient identifier (b)(6) for information related to ft4. The first sample initially resulted as 0. 312 uiu/ml for tsh, 4. 85 ng/ml for t3, and 17. 42 ug/dl for t4 when tested on the e601 analyzer. The sample was repeated on and advia centaur analyzer on (b)(6) 2016, resulting as 4. 01 uiu/ml for tsh, 0. 86 ng/ml for t3, and 8. 9 ug/dl for t4. The sample was repeated again on a second e601 analyzer at a second laboratory on (b)(6) 2016, resulting as 0. 288 uiu/ml for tsh, 6. 51 ng/ml for t3, and 21. 33 ug/dl for t4. The sample was repeated again on a second e601 analyzer at a second laboratory on (b)(6) 2016, resulting as 12. 65 pg/ml for ft3 and 4. 66 ng/dl for ft4. The sample was repeated again on the original e601 analyzer on (b)(6) 2016, resulting as 0. 158 uiu/ml for tsh, 3. 55 ng/ml for t3, 15. 45 ug/dl for t4, 8. 94 pg/ml for ft3, and 3. 73 ng/dl on ft4. The sample was repeated again on the advia centaur analyzer on (b)(6) 2016, resulting as 1. 86 uiu/ml for tsh, 0. 74 ng/ml for t3, 8. 7 ug/dl for t4, 2. 90 pg/ml for ft3, and 1. 36 ng/dl for ft4. The sample was also repeated again on a third e601 analyzer at a third laboratory on (b)(6) 2016, resulting as 0. 225 uiu/ml for tsh, 317. 1 ng/dl for t3, 16. 96 ug/dl for t4, 8. 88 pg/ml for ft3, and 3. 42 ng/dl for ft4. The second sample initially resulted as 0. 202 uiu/ml for tsh, 4. 50 ng/ml for t3, 14. 62 ug/dl for t4, 8. 72 pg/ml for ft3, and 3. 85 ng/dl on ft4. The second sample was repeated on an advia centaur analyzer on (b)(6) 2016, resulting as 2. 0 uiu/ml for tsh, 0. 78 ng/ml for t3, 8. 7 ug/dl for t4, 2. 82 pg/ml for ft3, and 1. 39 ng/dl for ft4. The patient was not adversely affected. The e601 analyzer used at the customer site was serial number (b)(4). The e601 analyzer used at the second laboratory was serial number (b)(4). The e601 analyzer used at the third laboratory was serial number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[44755791]
It has been clarified that the advia centaur analyzer results of 4. 01 uiu/ml for tsh, 0. 86 ng/ml for t3, and 8. 9 ug/dl for t4 from 03/24/2016 were reported outside of the laboratory.
Patient Sequence No: 1, Text Type: N, H10
[46765535]
A specific root cause could not be determined based on the provided information. A sample from the patient was requested for investigation, but could not be provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00455 |
| MDR Report Key | 5587344 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-04-20 |
| Date of Report | 2016-06-06 |
| Date of Event | 2016-03-24 |
| Date Mfgr Received | 2016-03-26 |
| Date Added to Maude | 2016-04-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| 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 |
| Generic Name | RADIOIMMUNOASSAY, TOTAL THYROXINE |
| Product Code | CDX |
| Date Received | 2016-04-20 |
| Model Number | NA |
| Catalog Number | 12017709122 |
| Lot Number | 188364 |
| ID Number | NA |
| Device Expiration Date | 2017-01-31 |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-20 |