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 2016-02-23 for ANTI-TSHR, ANTIBODIES TO TSH RECEPTOR manufactured by Roche Diagnostics.
[38857832]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
[38857833]
The customer complained that thyroid tests run by the roche method did not meet the clinical picture for 1 patient tested for free thyroxine (ft4 ii), free triiodothyronine (ft3), triiodothyronine (t3), thyroxine (t4) and antibodies to tsh receptor (anti-tshr). The thyroid values from the abbott method were normal. It is not known if erroneous results were reported outside of the laboratory. A customer in portugal sent the patient sample along with an email to a biochemist in a (b)(6). Information regarding this event came to the manufacturer from the (b)(6). The manufacturer is attempting to gather more details. This medwatch will cover anti-tshr. Refer to medwatch with a1 patient identifier (b)(4) for information on the ft4 ii erroneous results, medwatch with a1 patient identifier (b)(4) for information on the ft3 erroneous results, medwatch with a1 patient identifier (b)(4) for information on the t3 erroneous results, and medwatch with a1 patient identifier (b)(4) for information on the t4 erroneous results. Testing performed by the portugese customer determined the ft4 ii and ft3 results were very high, the t3 and t4 results were 3-4 times the normal range and the anti-tshr results were 10 times the normal range with the roche method. The tsh results for this patient were normal with the roche method and her past thyroid function was normal. The patient has no symptoms of hyperthyroidism. The customer suspects an interference in the sample. The (b)(6) hospital tested the sample on an abbott architect i2000 and the ft3, ft4 ii and tsh values were normal. The actual results were not provided. The anti-tshr result from the ria brahms method was 1. 9 ul/l which is in the grey zone of that assay. The sample was also treated with hbt scantibodies and tested for human anti-mouse antibodies (hama) and the result was negative. No repeat test results have been provided for the t3 and t4 tests. No adverse event occurred. The tests by the roche method were performed on an e601 analyzer. The serial number was not provided.
Patient Sequence No: 1, Text Type: D, B5
[40682684]
Due to lack of sample volume, further investigation of anti-tshr could not be performed. The elevated anti-tshr values could be affected by the presence of a streptavidin interfering factor previously identified for the ft4 and ft3 parameters. This specific interference is addressed in product labeling.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00203 |
| MDR Report Key | 5454924 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-02-23 |
| Date of Report | 2016-03-17 |
| Date of Event | 2016-01-01 |
| Date Mfgr Received | 2016-01-28 |
| Date Added to Maude | 2016-02-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | ANTI-TSHR, ANTIBODIES TO TSH RECEPTOR |
| Generic Name | ANTI-TSHR IMMUNOASSAY |
| Product Code | KLI |
| Date Received | 2016-02-23 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | ASKU |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| 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 | 2016-02-23 |