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 2018-02-27 for ELECSYS T4 ASSAY manufactured by Roche Diagnostics.
[101509598]
(b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[101509599]
The customer complained of high results for 1 patient sample tested for elecsys ft4 ii assay (ft4 ii) and elecsys ft3 iii (ft3 iii) on a cobas 6000 e 601 module. The initial ft3 iii and ft4 ii results were reported outside of the laboratory where the physician complained that the results did not correspond to the patient's clinical picture. The sample was sent for testing by the abbott method along with repeat testing with an edta plasma sample on the customer's e601 module and repeat testing on another hospitals e601 module. Based on the data provided, discrepant results were identified for ft4 ii, ft3 iii, elecsys t3 (t3) and elecsys t4 assay (t4). Refer to medwatches with the following patient identifiers for the assays involved: (b)(6). There was no allegation that an adverse event occurred. The customer's e601 serial number was (b)(4). The e601 serial number used at the external laboratory was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-00587 |
| MDR Report Key | 7300026 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-02-27 |
| Date of Report | 2018-03-20 |
| Date of Event | 2018-02-08 |
| Date Mfgr Received | 2018-02-08 |
| Date Added to Maude | 2018-02-27 |
| 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 | 2018-02-27 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | ASKU |
| 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 | 2018-02-27 |