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 2019-04-11 for ANTI-TSHR, ANTIBODIES TO TSH RECEPTOR 04388780190 manufactured by Roche Diagnostics.
[141588060]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[141588061]
The initial reporter complained of discrepant high results for 10 patient samples tested for elecsys anti-tshr immunoassay (anti-tshr) on a cobas 8000 e 602 module. No erroneous results were reported outside of the laboratory. The repeat results were believed to be correct. There was no allegation that an adverse event occurred. The e602 module serial number was (b)(4). The discrepant results were all from the same reagent pack and occurred within a short time period. Qc results were acceptable. The customer was not having problems with other assays run on the instrument. Calibration and qc were acceptable. Based on the calibration and qc data, a general reagent issue can be excluded. The issue may have been due to the presence of foam/bubbles on the surface of the reagent, however, the investigation was unable to determine the specific root cause of the event. The investigation did not identify a product problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-01427 |
| MDR Report Key | 8503037 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-04-11 |
| Date of Report | 2019-04-11 |
| Date of Event | 2019-03-16 |
| Date Mfgr Received | 2019-03-26 |
| Date Added to Maude | 2019-04-11 |
| 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 | 2019-04-11 |
| Model Number | NA |
| Catalog Number | 04388780190 |
| Lot Number | 33584301 |
| Device Expiration Date | 2019-08-31 |
| 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 | 2019-04-11 |