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 2018-02-19 for ELECSYS T4 ASSAY manufactured by Roche Diagnostics.
[100551750]
(b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[100551751]
The customer complained of questionable results for 1 patient sample tested for elecsys tsh assay, elecsys t4 assay (t4), elecsys t3 (t3), elecsys ft3 iii (ft3 iii), elecsys ft4 ii assay, roche diagnostics cobas elecsys anti-tpo (anti-tpo), and roche diagnostics elecsys anti-tg. The patient samples were tested on two different cobas 8000 e 602 modules and compared to an abbott system. "(b)(6)" cobas e602 serial number was (b)(4) and "(b)(6)" cobas e602 serial number was (b)(4). Of the data provided, there were reportable malfunctions for t4, t3, ft3 iii, and anti-tpo. The erroneous results were reported outside of the laboratory. There was no allegation of an adverse event. The patient has no clinical symptoms of thyroid disease. An interfering factor is believed to present, but a patient sample can not be shipped for further analysis due to (b)(6) export customs. Medwatches for this event include those with (b)(6). The investigation is currently ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-00492 |
| MDR Report Key | 7279701 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-02-19 |
| Date of Report | 2018-03-07 |
| Date of Event | 2018-02-01 |
| Date Mfgr Received | 2018-02-01 |
| Date Added to Maude | 2018-02-19 |
| 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 | 2018-02-19 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | 248077 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2018-02-19 |