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 2019-03-15 for ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO 07026935190 manufactured by Roche Diagnostics.
[138969155]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[138969156]
The initial reporter stated that they received erroneous results for one patient sample tested with elecsys ft3 iii, the elecsys ft4 iii assay, the elecsys ft4 ii assay, the elecsys anti-tshr immunoassay, and roche diagnostics cobas elecsys anti-tpo on a cobas 8000 e 801 module. The erroneous results were reported outside of the laboratory. This medwatch will apply to the anti-tpo assay. Please refer to the medwatch with patient identifier (b)(6) for information related to the ft3 assay, refer to the medwatch with patient identifier (b)(6) for information related to the ft4 iii assay, refer to the medwatch with patient identifier (b)(6) for information related to the anti-tshr assay, and refer to the medwatch with patient identifier (b)(6) for information related to the ft4 ii assay. The sample was initially tested at the customer site on the e 801 analyzer on (b)(6) 2019. The sample was also repeated for ft3, ft4, and anti-tpo using the abbott method. The sample was repeated for anti-tshr using the yamasa method. The sample was provided for investigation, where it was tested on a second e 801 analyzer on (b)(6) 2019. No adverse events were alleged to have occurred with the patient. The serial number of the e 801 analyzer used at the customer site was asked for, but not provided. The serial number of the e 801 analyzer used for investigation is (b)(4). Based on the provided information, a general reagent issue can most likely be excluded. The investigation could not identify a product problem. The cause of the event could not be determined.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-01091 |
| MDR Report Key | 8425668 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-03-15 |
| Date of Report | 2019-03-18 |
| Date of Event | 2019-02-08 |
| Date Mfgr Received | 2019-03-13 |
| Date Added to Maude | 2019-03-15 |
| 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 | 2019-03-15 |
| Model Number | NA |
| Catalog Number | 07026935190 |
| Lot Number | ASKU |
| 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 | 2019-03-15 |