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 2018-10-31 for ELECSYS T4 ASSAY 07027885190 manufactured by Roche Diagnostics.
[126663059]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[126663060]
The customer stated that they received erroneous results for two patient samples tested with elecsys t3 on a cobas 8000 e 801 module. The second sample also had an erroneous result for the elecsys t4 assay when tested on the same e 801 analyzer. No erroneous results were reported outside of the laboratory. This medwatch will apply to the t4 assay. Patient identifier (b)(6) for information related to the t3 assay. Refer to the attachment for all patient data. The erroneous results are highlighted in red. The correct results which were reported outside of the laboratory are highlighted in yellow. All erroneous results were generated on the e 801 analyzer. The samples were repeated on 4 different roche diagnostics elecsys e170 modular analytics immunoassay analyzers. No adverse events were alleged to have occurred with the patients. The serial number of the e 801 analyzer is (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-03954 |
| MDR Report Key | 8023317 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-10-31 |
| Date of Report | 2018-11-13 |
| Date of Event | 2018-10-05 |
| Date Mfgr Received | 2018-10-11 |
| Date Added to Maude | 2018-10-31 |
| 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 | 2018-10-31 |
| Model Number | NA |
| Catalog Number | 07027885190 |
| Lot Number | 287093 |
| Device Expiration Date | 2019-03-31 |
| 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 | 2018-10-31 |