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 2017-11-29 for ELECSYS T4 ASSAY 12017709122 manufactured by Roche Diagnostics.
[93867872]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[93867873]
The customer received questionable results for multiple assays for one patient from an unknown roche analyzer. The results were reported to the endocrinologist. The patient was under growth hormone supplementation therapy with saizen and the endocrinologist claimed the results did not fit the clinical picture. Interference was suspected. Of the data provided only the results for elecsys tsh assay, elecsys t4 assay, and elecsys estradiol iii assay were a reportable malfunction. Refer to the attachment to the medwatch for all patient data. There was no allegation of an adverse event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02772 |
| MDR Report Key | 7067047 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-11-29 |
| Date of Report | 2017-12-19 |
| Date of Event | 2017-03-07 |
| Date Mfgr Received | 2017-11-09 |
| Date Added to Maude | 2017-11-29 |
| 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 |
| 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 | 2017-11-29 |
| Model Number | NA |
| Catalog Number | 12017709122 |
| Lot Number | 19428105 |
| 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 | 2017-11-29 |