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 2019-03-22 for ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO 06368590190 manufactured by Roche Diagnostics.
[139711752]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[139711753]
The initial reporter questioned results for 37 patient samples tested for cobas elecsys anti-tpo (anti-tpo) on a cobas 6000 e 601 module. The customer repeated 37 patient samples that had originally been released from the laboratory. Of that data, the results for 6 patient samples were discrepant. The customer is not sure which result is correct. There was no allegation that an adverse event occurred. The e601 module serial number is (b)(4). Qc results show a large scatter. Calibration data also shows large variations in signals. Sample pipetting error messages were observed on the alarm trace data from (b)(6) 2019. The measuring cell had been replaced during the annual preventive maintenance visit on 23-jan-2019. The customer stated they had water quality issues recently. The water filters were replaced on 18-mar-2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-01181 |
| MDR Report Key | 8443566 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-03-22 |
| Date of Report | 2019-04-09 |
| Date of Event | 2019-03-04 |
| Date Mfgr Received | 2019-03-07 |
| Date Added to Maude | 2019-03-22 |
| 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 | 2019-03-22 |
| Model Number | NA |
| Catalog Number | 06368590190 |
| Lot Number | 34258403 |
| 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 | 2019-03-22 |