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 2018-10-15 for ELECSYS T4 ASSAY manufactured by Roche Diagnostics.
[123868412]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[123868413]
The customer received questionable thyroid results for one patient sample from cobas 8000 cobas e 602 module serial number (b)(4) when compared to the results from an abbott architect. The results from the cobas e602 did not correlate with patient symptom and an interference was suspected. This medwatch is for elecsys t4 assay. Refer to the following medwatch with patient identifier for the other assays involved: elecsys tsh assay=(b)(6). Elecsys t3 assay=(b)(6). Elecsys ft3=(b)(6). Elecsys ft4 assay=(b)(6). The erroneous results were reported outside of the laboratory. There was no allegation of an adverse event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-03669 |
| MDR Report Key | 7965362 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-10-15 |
| Date of Report | 2019-01-07 |
| Date of Event | 2018-09-18 |
| Date Mfgr Received | 2018-09-26 |
| Date Added to Maude | 2018-10-15 |
| 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 |
| 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 | ELECSYS T4 ASSAY |
| Generic Name | RADIOIMMUNOASSAY, TOTAL THYROXINE |
| Product Code | CDX |
| Date Received | 2018-10-15 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | ASKU |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-10-15 |