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 07027885190 manufactured by Roche Diagnostics.
[100567211]
(b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[100567212]
The customer complained of questionable results for 3 patient samples tested for elecsys tsh assay (tsh), elecsys t4 assay (t4), elecsys t3 (t3), elecsys ft3 iii (ft3 iii), and elecsys ft4 ii assay (ft4 ii). The patient samples were tested on a cobas 8000 e 801 module, cobas 8000 e 602, cobas 8000 e 601, roche diagnostics elecsys e170 modular analytics immunoassay analyzer, and a siemens centauro. Of the data provided for 3 patients, 1 patient had reportable malfunctions for tsh, t4, and t3, 1 patient had reportable malfunctions for tsh, t4, t3, and ft4 ii, and 1 patient had a reportable malfunction for t4. The erroneous results were not reported outside of the laboratory. There was no allegation of an adverse event. Medwatches for this event include those with (b)(6). The investigation is currently ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-00506 |
| MDR Report Key | 7279881 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-02-19 |
| Date of Report | 2018-06-21 |
| Date of Event | 2018-01-24 |
| Date Mfgr Received | 2018-01-31 |
| 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 | 07027885190 |
| Lot Number | 194309 |
| 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 | 2018-02-19 |