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 2019-02-12 for ANTI-TSHR, ANTIBODIES TO TSH RECEPTOR 04388780190 manufactured by Roche Diagnostics.
[136004836]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[136004837]
The customer stated that they received erroneous results for one patient sample tested with elecsys ft3 iii, the elecsys ft4 ii assay, and the elecsys anti-tshr immunoassay on a cobas e 411 immunoassay analyzer. The ft3 and ft4 results from the e411 analyzer were higher than results obtained on an abbott architect analyzer. The physician also doubts the non-reactive anti-tshr result from the e411 analyzer. 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. The patient sample was initially tested on the customer's e411 analyzer on (b)(6) 2018. The sample was repeated for ft3 and ft4 on an abbott architect analyzer. The sample was repeated for anti-tshr using the yamasa method. The sample was also provided for investigation where it was tested on an e 801 analyzer. No adverse events were alleged to have occurred with the patient. The serial number of the customer's e411 analyzer is (b)(4). The serial number of the e 801 analyzer used for investigation is (b)(4). Anti-tshr reagent lot number 359355, with an expiration date of november 2019 was used on this analyzer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-00577 |
| MDR Report Key | 8332916 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-02-12 |
| Date of Report | 2019-02-26 |
| Date of Event | 2018-12-19 |
| Date Mfgr Received | 2019-01-21 |
| Date Added to Maude | 2019-02-12 |
| 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 | 2019-02-12 |
| Model Number | NA |
| Catalog Number | 04388780190 |
| Lot Number | ASKU |
| 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 | 2019-02-12 |