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 2016-02-26 for T4 manufactured by Roche Diagnostics.
[39201369]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[39201370]
The customer complained of erroneous results for 1 patient tested for triiodothyronine (t3), thyroxine (t4) and thyrotropin (tsh). Comparison testing was being performed between an e411 analyzer, an e601 analyzer, an abbott architect method and the siemens centaur method. The tsh results from the e411 analyzer were erroneous and the t3, t4 and tsh results from the e601 analyzer were erroneous. It is not known if erroneous results were reported outside of the laboratory. This information has been requested. This medwatch will cover the t4 reagent used with the e601 analyzer. (b)(6) for information on the tsh reagent used with the e411 analyzer. (b)(6) for the tsh reagent used with the e601 analyzer. (b)(6) for the t3 reagent used with the e601 analyzer. The initial tsh result from the e411 analyzer was 1. 84 uiu/ml. The sample was repeated in another laboratory on an abbott architect analyzer and the result was 4. 43 uiu/ml. A new sample was obtained on (b)(6) 2016 and tested on the abbott architect analyzer and the tsh result was 5. 23 uiu/ml. The sample from (b)(6) 2016 was repeated on an e601 analyzer and the tsh result was 1. 67 uiu/ml, the t3 result was >651 ng/dl and the t4 result was >24. 86 ug/dl. The sample from (b)(6) 2016 was also repeated by the siemens-centaur analyzer and the tsh result was 7. 72 uiu/ml, the t3 result was 125. 1 ng/dl and the t4 result was 6. 5 ug/dl. Additional results from a sample obtained on (b)(6) 2016 were provided. The tsh result was 5. 710 uiu/ml, the t3 result was 112. 70 ng/dl and the t4 result was 6. 50 ug/dl. It is not clear what analyzer these results are from. This information has been requested. It is not known if an adverse event occurred. No adverse event was reported. The e411 analyzer serial number was (b)(4). The e601 analyzer serial number was requested but not provided.
Patient Sequence No: 1, Text Type: D, B5
[39351974]
The t3 result of >651 ng/dl and the t4 result of >24. 86 had data flags. These results were not reported outside of the laboratory. The serial number for the e601 analyzer is (b)(4). The tsh result of 5. 710 uiu/ml, the t3 result of 112. 70 ng/dl and the t4 result of 6. 50 ug/dl were from the (b)(6) 2016 sample that was sent to a 3rd laboratory for repeat testing.
Patient Sequence No: 1, Text Type: N, H10
[42534474]
A specific root cause could not be identified. Additional information for further investigation was requested but was not provided. Based on the information provided, a general reagent issue at the customer site can be excluded. A potential reason for the differences in the t4 results may be related to an interfering factor in the samples that affects the results produced by the assays from different manufacturers.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00222 |
| MDR Report Key | 5463662 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-02-26 |
| Date of Report | 2016-04-13 |
| Date of Event | 2016-01-23 |
| Date Mfgr Received | 2016-02-01 |
| Date Added to Maude | 2016-02-26 |
| 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 | 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 | 2016-02-26 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | ASKU |
| ID Number | NA |
| 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 | 2016-02-26 |