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 2019-02-21 for ELECSYS T4 ASSAY manufactured by Roche Diagnostics.
[136740066]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[136740067]
The customer complained of discrepant results for 1 patient sample tested for elecsys t4 (t4) and elecsys t3 (t3) on a cobas e801 module and a cobas 6000 e 601 module compared to the abbott method. This medwatch will cover t4 on the e601 module. Refer to medwatch with patient identifier (b)(6) for information on the t4 results on the e801 module, medwatch with patient identifier (b)(6) for information on the t3 results on the e801 module and medwatch with patient identifier (b)(6) for information on the t3 results on the e601 module. The erroneous results were not reported outside of the laboratory. There was no allegation that an adverse event occurred. The e801 module serial number was (b)(4). The e601 module serial number was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-00719 |
| MDR Report Key | 8357575 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-02-21 |
| Date of Report | 2019-05-09 |
| Date of Event | 2018-11-23 |
| Date Mfgr Received | 2019-02-06 |
| Date Added to Maude | 2019-02-21 |
| 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 | 2019-02-21 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | ASKU |
| 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 | 2019-02-21 |