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 2018-10-30 for ELECSYS T4 ASSAY 07027885190 manufactured by Roche Diagnostics.
[125784877]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[125784878]
The customer stated that they received erroneous results for one patient sample tested with the elecsys t4 assay on a cobas 8000 e 801 module. The erroneous results were not reported outside of the laboratory. The sample was tested three times on the customer's e 801 analyzer, resulting with t4 values of 24. 4 ug/dl, 24. 9 ug/dl accompanied by a data flag, and 21. 6 ug/dl. The sample was tested at another laboratory on a cobas 6000 e 601 module, resulting with a t4 value of 12. 21 ug/dl. No adverse events were alleged to have occurred with the patient. The serial number of the customer's e 801 analyzer is (b)(4). The serial number of the e 601 analyzer used at the other laboratory was asked for, but not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-03894 |
| MDR Report Key | 8018332 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-10-30 |
| Date of Report | 2018-12-27 |
| Date of Event | 2018-10-09 |
| Date Mfgr Received | 2018-10-09 |
| Date Added to Maude | 2018-10-30 |
| 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 | 2018-10-30 |
| 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 | 2018-10-30 |