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 2017-07-10 for ELECSYS T4 ASSAY 12017709122 manufactured by Roche Diagnostics.
[79974279]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[79974280]
The customer complained of erroneous results for 1 patient sample tested for elecsys t4 assay (t4). It is not known if erroneous results were reported outside of the laboratory. The customer complained that there were "huge deviations" for 1 sample tested for t4. No actual comparison data was provided. One result of 24. 86 ug/dl was provided. It is not known if this was an initial result or a repeat result. There was no allegation that an adverse event occurred. The instrument type and serial number was not provided. The customer later provided quality control (qc) results which indicated that the t4 reagent expired on 01/31/2017. No further information was provided by the customer. A specific root cause could not be identified. Additional information was requested for investigation but was not provided. Since no additional information was provided, the investigation could not be completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01411 |
| MDR Report Key | 6696387 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-07-10 |
| Date of Report | 2017-07-10 |
| Date of Event | 2017-06-20 |
| Date Mfgr Received | 2017-06-21 |
| Date Added to Maude | 2017-07-10 |
| 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 | 2017-07-10 |
| Model Number | NA |
| Catalog Number | 12017709122 |
| Lot Number | 188364 |
| ID Number | NA |
| Device Expiration Date | 2017-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2017-07-10 |