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 2019-05-15 for ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO 06368590190 manufactured by Roche Diagnostics.
[145101504]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[145101505]
The initial reporter complained of discrepant results for 2 patient samples tested for elecsys ft4 iii (ft4 iii), elecsys tsh (tsh) and elecsys anti-tpo (anti-tpo) on a cobas e801 module compared to the abbott architect method. This medwatch will cover anti-tpo. Refer to medwatch with patient identifier (b)(6) for information on the ft4 iii results and medwatch with patient identifier (b)(6) for information on the tsh results. The results from the e801 module were reported outside of the laboratory. The customer doesn't think the roche results are correct as they don't correspond to the patients' medical history or clinical picture. There was no allegation that an adverse event occurred. The e801 module serial number was (b)(4). The customer suspects an interference in the patient samples affecting the results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-01812 |
| MDR Report Key | 8611212 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-05-15 |
| Date of Report | 2019-07-25 |
| Date of Event | 2019-04-01 |
| Date Mfgr Received | 2019-04-24 |
| Date Added to Maude | 2019-05-15 |
| 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 | 2019-05-15 |
| Model Number | NA |
| Catalog Number | 06368590190 |
| Lot Number | 36832100 |
| 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 | 2019-05-15 |