MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-03-04 for ACL 2000/ANTI-THROMBIN III 106 manufactured by Instrumentation Laboratories.
[18399]
A pt was treated based on erroneous results from device. A value of 139% and 180%; based on a "linearity" range of 0-150%, results were reported. However, the specified range for device is 0-120%; the flagging range for the unit (0-150%) was mistaken for reagent linearity. Although customer initially refused to release info on pt condition, they later advised the pt died.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 67955-1996-09001 |
| MDR Report Key | 32178 |
| Date Received | 1996-03-04 |
| Date of Report | 1996-02-27 |
| Date Facility Aware | 1996-02-23 |
| Report Date | 1996-02-27 |
| Date Reported to Mfgr | 1996-02-27 |
| Date Added to Maude | 1996-04-25 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACL 2000/ANTI-THROMBIN III |
| Generic Name | COAGULATION INSTRUMENTATION & REAGENTS |
| Product Code | JPE |
| Date Received | 1996-03-04 |
| Model Number | 106 |
| Lot Number | 951016 |
| Operator | OTHER |
| Device Availability | * |
| Device Age | NO INFO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 33426 |
| Manufacturer | INSTRUMENTATION LABORATORIES |
| Manufacturer Address | 101 HARTWELL AVE LEXINGTON MA 02173 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1996-03-04 |