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 2019-03-18 for ANTI-TSHR, ANTIBODIES TO TSH RECEPTOR 07026951190 manufactured by Roche Diagnostics.
[139102520]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[139102521]
The customer complained of questionable elecsys tsh assay results tested on a cobas 8000 e 602 module and elecsys ft4 iii assay, elecsys ft3 iii, and elecsys anti-tshr immunoassay results tested on a cobas 8000 e 801 module for 1 patient sample compared to competitor methods. The e 801 serial number was (b)(4). The e 602 serial number was not provided. This medwatch will cover anti-tshr. Refer to medwatch with patient identifier (b)(6) for information on the ft4 iii results, medwatch with patient identifier (b)(6) for information on the ft3 iii results, and medwatch with patient identifier (b)(6) for information on the tsh results. The tsh result was 0. 18 iu/l on the e 602 and 1. 62 iu/l on the beckman dxi access. The ft4 iii result was >100 pmol/l on the e 801 and 16. 73 pmol/l on the siemens centaur. The ft3 iii result was 17. 1 pmol/l on the e 801 and 4. 915 pmol/l on the siemens centaur. The anti-tshr result was >40 iu/l on the e 801 and <0. 9 iu/l on the thermo fisher brahms kryptor. The results from the e 801 and the e 602 were reported outside of the laboratory and the physician questioned the results. There was no adverse event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-01123 |
| MDR Report Key | 8429153 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-03-18 |
| Date of Report | 2019-04-25 |
| Date of Event | 2019-01-28 |
| Date Mfgr Received | 2019-03-01 |
| Date Added to Maude | 2019-03-18 |
| 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 | 2019-03-18 |
| Model Number | NA |
| Catalog Number | 07026951190 |
| Lot Number | 35935501 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2019-03-18 |