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 2018-11-26 for ELECSYS T4 ASSAY 07027885190 manufactured by Roche Diagnostics.
[128397332]
The event occurred in: (b)(6). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[128397333]
The customer complained of questionable results for multiple tests for multiple patients. From the data provided a reportable malfunction was provided for the following number of patients for the following tests: 4 patients for elecsys tsh assay, 7 patients for elecsys t3, 5 patients for elecsys t4 assay, 2 patients for elecsys ft4 ii assay, 1 patient for roche diagnostics cobas elecsys anti-tpo, and 1 patient for elecsys estradiol ii assay (e2). The customer performed their testing on a cobas 8000 e 801 module and a cobas 6000 e 601 module. The results were compared to an outside laboratories cobas e801, cobas e601, a roche diagnostics elecsys e170 modular analytics immunoassay analyzer, and a siemens centaur. This medwatch will cover t4. Please refer to the following medwatches with the following patient identifiers. (b)(6) for tsh; (b)(6) for t3; (b)(6) for ft4; (b)(6) for anti-tpo; (b)(6) for e2. Refer to the attachment for patient data. The discrepant results are highlighted. The patient information that was provided is included in the attachment. It was unknown if the erroneous results were reported outside of the laboratory. There was no allegation of an adverse event. The customer's cobas e801 serial number was (b)(4). The customer's cobas e601 serial number information was not provided. The investigation is currently ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-04468 |
| MDR Report Key | 8103535 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-11-26 |
| Date of Report | 2019-02-14 |
| Date of Event | 2018-08-18 |
| Date Mfgr Received | 2018-11-01 |
| Date Added to Maude | 2018-11-26 |
| 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 | 2018-11-26 |
| Model Number | NA |
| Catalog Number | 07027885190 |
| Lot Number | 28709300 |
| 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 | 2018-11-26 |