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 2018-08-16 for ELECSYS T4 ASSAY 12017709122 manufactured by Roche Diagnostics.
[117450170]
The event occurred in: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[117450171]
The customer complained of questionable thyroid results for 1 patient tested on a cobas 6000 e 601 module compared to competitor (abbott and ria) results. The customer stated that the patient's elecsys t3 and elecsys t4 assay results were similar before and after t3/t4 supplementation and they did not consider that reasonable. From the data provided, a reportable malfunction was provided for t3, t4, elecsys ft4 ii assay, and elecsys tsh assay. The specific date of testing for the data that is a reportable malfunction is not known, but clarification has been requested. This medwatch will cover the t4 data. Refer to medwatch with patient identifier (b)(6) for information on the t3 results. Refer to medwatch with patient identifier (b)(6) for information on the ft4 ii results. Refer to medwatch with patient identifier (b)(6) for information on the tsh results. The customer did not provide the thyroid data for the time period before the patient was taking t3/t4 supplements. The customer performed multiple dilutions of different dilution factors using two different diluents, but product labeling does not support dilution testing. The erroneous results were not released outside of the laboratory. There was no allegation of an adverse event. The cobas e601 serial number was (b)(4). The investigation is currently ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-02742 |
| MDR Report Key | 7790435 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-08-16 |
| Date of Report | 2018-10-08 |
| Date of Event | 2018-06-20 |
| Date Mfgr Received | 2018-07-30 |
| Date Added to Maude | 2018-08-16 |
| 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 | 2018-08-16 |
| Model Number | NA |
| Catalog Number | 12017709122 |
| Lot Number | 248077 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2018-08-16 |