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 2017-11-09 for ELECSYS T4 ASSAY 12017709122 manufactured by Roche Diagnostics.
[92610647]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[92610648]
The customer stated that they received an erroneous result for one patient sample tested for the elecsys t4 assay (t4) on a cobas e 411 immunoassay analyzer (e411). The erroneous result was not reported outside of the laboratory. The sample resulted with a t4 value of 18 ug/ml when tested on the customer's e411 analyzer. The sample was tested on a vidas analyzer and the t4 result was 9 ug/ml. The sample was also tested on a second e411 analyzer in a different laboratory, resulting with a t4 value of 20 ug/ml. A fresh sample was collected from the patient and tested. The values from this sample were the same as previous values. No adverse events were alleged to have occurred with the patient. The serial numbers of the e411 analyzers used at the customer site and other laboratory were asked for, but not provided. The customer does not use quality control material. During troubleshooting, quality control material was tested on the customer's e411 analyzer and recovered within limits. Calibration signals were within range on the customer's e411 analyzer. No issues were found with the customer's e411 analyzer. Calibration and quality control recoveries at the other laboratory were within limits.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02563 |
| MDR Report Key | 7013360 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-11-09 |
| Date of Report | 2017-11-21 |
| Date of Event | 2017-10-20 |
| Date Mfgr Received | 2017-10-20 |
| Date Added to Maude | 2017-11-09 |
| 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 | 2017-11-09 |
| Model Number | NA |
| Catalog Number | 12017709122 |
| Lot Number | 248077 |
| 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 | 2017-11-09 |