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 2017-12-21 for ELECSYS T4 ASSAY 12017709122 manufactured by Roche Diagnostics.
[95824120]
(b)(4). The event occurred in: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[95824121]
The customer received questionable thyroid results for 2 patient samples. Of the data provided, the elecsys t4 assay results that are a reportable malfunction apply to only 1 patient sample that was tested on a cobas 6000 e 601 module (serial number not provided) compared to the t4 results from a siemens-immulite 2000xpi, abbott-architect, and a beckman coulter. Please refer to the attachment for patient data. The erroneous results were not reported outside of the laboratory. There was no allegation of an adverse event. This medwatch will cover t4. Refer to medwatch with patient identifier (b)(6) for information on the ft3 iii erroneous results, medwatch with patient identifier(b)(6) for information on the t3 erroneous results, and medwatch with patient identifier (b)(6) for information on the ft4 ii erroneous result. The investigation is currently ongoing.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1823260-2017-03102 |
MDR Report Key | 7139331 |
Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
Date Received | 2017-12-21 |
Date of Report | 2018-01-24 |
Date of Event | 2017-12-06 |
Date Mfgr Received | 2017-12-14 |
Date Added to Maude | 2017-12-21 |
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 |
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 | 2017-12-21 |
Model Number | NA |
Catalog Number | 12017709122 |
Lot Number | 194281 |
ID Number | NA |
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 | 2017-12-21 |