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 2018-12-11 for ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO 06368590190 manufactured by Roche Diagnostics.
[130631403]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[130631404]
The customer questioned results for 2 samples from 1 patient tested for elecsys tsh assay (tsh), elecsys t3 (t3), elecsys ft4 ii assay (ft4 ii), elecsys anti-tpo (anti-tpo), elecsys anti-tg (anti-tg) and elecsys anti-tshr immunoassay on a cobas 6000 e 601 module compared to the centaur and ria methods. Based on the data provided, the tsh, t3, ft4 ii, anti-tpo and anti-tshr results were discrepant. This medwatch will cover anti-tpo. Refer to medwatch with patient identifier (b)(6) for information on the tsh results, medwatch with patient identifier (b)(6) for information on the t3 results, medwatch with patient identifier (b)(6) for information on the ft4 ii results and medwatch with patient identifier (b)(6) for information on the anti-tshr results. It is not known if the erroneous results were reported outside of the laboratory. There was no allegation that an adverse event occurred. The customer suspects an interference affecting the results. The e601 module serial number was (b)(4). The samples were requested for investigation but could not be provided. Based on the calibration and qc data, a general reagent issue can be excluded. Since the sample could not be provided, the investigation could not be completed. The investigation did not identify a product problem. The cause of the event could not be determined.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-04785 |
| MDR Report Key | 8151780 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-12-11 |
| Date of Report | 2018-12-11 |
| Date of Event | 2018-11-21 |
| Date Mfgr Received | 2018-11-23 |
| Date Added to Maude | 2018-12-11 |
| 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 | ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO |
| Generic Name | SYSTEM, TEST, THYROID AUTOANTIBODY |
| Product Code | JZO |
| Date Received | 2018-12-11 |
| Model Number | NA |
| Catalog Number | 06368590190 |
| Lot Number | 341164 |
| 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 | 2018-12-11 |