MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-06-24 for ASSYM * manufactured by Abbott Diagnostics.
[62306]
Pt had a t4 performed on the axsym on 5/20/97 in the evening and a result of 3. 7 was reported. Upon further evaluation of this test result on the morning of 5/21/97 it was decided to redraw the pt and double check this t4 on the redrawn specimen. The original specimen from 5/20/97 was also retested and resulted in a normal result comparable to the redrawn specimen. This discrepancy in the t4 results was reported as possibly due to an instrument error.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1011558 |
| MDR Report Key | 100287 |
| Date Received | 1997-06-24 |
| Date of Report | 1997-06-17 |
| Date of Event | 1997-05-21 |
| Date Added to Maude | 1997-06-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASSYM |
| Generic Name | IMMUNOASSAY INSTRUMENTATION |
| Product Code | LCI |
| Date Received | 1997-06-24 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 7563 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 98800 |
| Manufacturer | ABBOTT DIAGNOSTICS |
| Manufacturer Address | 1 ABBOTT LANE ABBOTT PARK IL 60064 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-06-24 |