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 2018-02-05 for ELECSYS T4 ASSAY 12017709122 manufactured by Roche Diagnostics.
[99781662]
(b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[99781666]
The customer complained of questionable results for 3 separate samples from 1 patient tested for multiple tests on both a cobas 8000 e 602 module or a cobas 8000 e 801 module. Of the data provided, the elecsys tsh assay tsh (tsh), elecsys ft3 iii (ft3 iii), elecsys t4 assay (t4), and elecsys t3 (t3) results from one sample were a reportable malfunction. This one sample was drawn on (b)(6) 2018 and tested on a cobas e602 with the results compared to an abbott system. The customer complained that the patient results do no meet the clinical picture of the patient. The cobas e602 serial number was (b)(4). The rerun results from the sample drawn (b)(6) 2019 are not comparable to the original data since the sample had polyethylene glycol (peg) treatment performed. Samples with peg and without peg treatment are not comparable. The erroneous results were not reported outside of the laboratory. There was no allegation of an adverse event. Medwatchs for this issue include those with (b)(6). The investigation is currently ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-00334 |
| MDR Report Key | 7241291 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-02-05 |
| Date of Report | 2018-03-07 |
| Date of Event | 2018-01-20 |
| Date Mfgr Received | 2018-01-20 |
| Date Added to Maude | 2018-02-05 |
| 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 | 2018-02-05 |
| Model Number | NA |
| Catalog Number | 12017709122 |
| Lot Number | 19428101 |
| 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 | 2018-02-05 |