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 2019-05-29 for ANTI-TSHR, ANTIBODIES TO TSH RECEPTOR 07026951190 manufactured by Roche Diagnostics.
[146385796]
The patient sample was provided for investigation. During the investigation, ft3 and ft4 measurements from the sample were above the respective assay ranges. The presence of an interfering factor against streptavidin used in the ft3 and ft4 reagents could be excluded. The investigation is currently ongoing. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[146385817]
The initial reporter stated that they received discrepant results for one patient sample tested with elecsys ft3 iii, the elecsys ft4 iii assay, and the elecsys anti-tshr immunoassay on a cobas 8000 e 801 module. The values did not match when compared to competitor methods. The values from the e 801 analyzer were reported outside of the laboratory and the competitor method results were believed to be correct. Until 2012, the patient had ft3, ft4, and tsh values which were within the reference range of the assays. Since (b)(6) 2013, the patient's ft3, ft4, and anti-tshr values have been increasing while tsh values are still normal. This medwatch will apply to the anti-tshr assay. Please refer to the medwatch with patient identifier (b)(6) for information related to the ft3 assay and refer to the medwatch with patient identifier (b)(6) for information related to the ft4 assay. When tested on the e 801 analyzer, the sample resulted with a ft3 value of 7. 63 pmol/l and when repeated on a siemens centaur analyzer, the value was 3. 6 ng/l. When tested on the e 801 analyzer, the sample resulted with a ft4 value of 42. 7 pmol/l and when repeated on a siemens centaur analyzer, the value was 1. 4 ng/dl. When tested on the e 801 analyzer, the sample resulted with an anti-tshr value of 11. 9 iu/l and when repeated on a thermo fisher cryptor analyzer, the value was normal. No adverse events were alleged to have occurred with the patient. The serial number of the e 801 analyzer is (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-01987 |
| MDR Report Key | 8649782 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-05-29 |
| Date of Report | 2019-07-03 |
| Date of Event | 2019-04-09 |
| Date Mfgr Received | 2019-05-03 |
| Date Added to Maude | 2019-05-29 |
| 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 | ANTI-TSHR, ANTIBODIES TO TSH RECEPTOR |
| Generic Name | ANTI-TSHR IMMUNOASSAY |
| Product Code | JZO |
| Date Received | 2019-05-29 |
| Model Number | ANTI-TSHR |
| Catalog Number | 07026951190 |
| Lot Number | 35935501 |
| Device Expiration Date | 2019-11-30 |
| 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 | 2019-05-29 |