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 2018-12-13 for ELECSYS T4 ASSAY manufactured by Roche Diagnostics.
[130478331]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[130478332]
The customer complained of questionable thyroid results for 1 patient sample on a cobas 6000 e 601 module. Of the data provided, discrepant results were identified for elecsys t3, elecsys ft3 iii, elecsys t4, and elecsys ft4 ii assay on the e601 module and a cobas 6000 e 801 module compared to the bayer centaur method. The erroneous results were reported outside of the laboratory. This medwatch will cover t4. Refer to medwatch with patient identifier (b)(6) for information on the t3 results, medwatch with patient identifier (b)(6) for information on the ft3 iii results, and medwatch with patient identifier (b)(6) for information on the ft4 ii results. There was no allegation of an adverse event. The customer's cobas e601 serial number was (b)(4). The customer's cobas e801 serial number was (b)(4). The ft3 iii reagent lot number used on the cobas e601 was 303235. The t3, t4, and ft4 ii reagent lot numbers used on the cobas e601 were not provided. The t3 reagent lot number used on the cobas e801 was 291614. The ft3 iii reagent lot number used on the cobas e801 was 314824. The t4 reagent lot number used on the cobas e801 was 287093. The ft4 ii reagent lot number used on the cobas e801 was 303203. The reagent expiration dates were not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-04856 |
| MDR Report Key | 8161640 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-12-13 |
| Date of Report | 2019-02-04 |
| Date of Event | 2018-11-09 |
| Date Mfgr Received | 2018-11-26 |
| Date Added to Maude | 2018-12-13 |
| 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 | ELECSYS T4 ASSAY |
| Generic Name | RADIOIMMUNOASSAY, TOTAL THYROXINE |
| Product Code | CDX |
| Date Received | 2018-12-13 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | 30320300 |
| 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 | 2018-12-13 |