FDA Adverse Event
Death
Summary report: N
ACL 200
MDR report key: 287344
·
Received July 27, 2000
Report
- Report Number
- 1217183-2000-00002
- Event Type
- Death
- Date Received
- July 27, 2000
- Date of Event
- April 1, 2000
- Report Date
- July 26, 2000
- Manufacturer
- INSTRUMENTATION LABORATORY SPA
- Product Code
- GKP
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
CUSTOMER FILED A MEDWATCH REPORT TO FDA ON 6/21/00, WHICH WAS SUBSEQUENTLY REPORTED BY THE FDA TO THE DISTRIBUTOR, BECKMAN COULTER, ON 7/24/00 WHO IN TURN NOTIFIED INSTRUMENTATION LABORATORY ON 7/25/00. THE INITIAL CUSTOMER REPORT CLAIMED THAT THE INR CALCULATION DEFAULT WAS NOT PROPERLY INSTALLED WHEN THEIR ACL 200 COAGULATION INSTRUMENT WAS UPGRADED WITH Y2K PREPAREDNESS SOFTWARE. ACCORDING TO THEIR REPORT, AN ERRONEOUS INR VALUE WAS REPORTED AND CONSEQUENTLY A PT'S COUMADIN THERAPY WAS ADJUSTED RESULTING IN OVERMEDICATION AND DEATH. THE SOFTWARE AND QUALITY CONTROL MATERIAL FAILED TO IDENTIFY THE ERROR. INCIDENT OCCURRED ON 4/1/00, AND THE INSTRUMENT ERROR WAS IDENTIFIED AND CORRECTED ON 4/12/00.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACL 200 | AUTOMATED COAGULATION INSTRUMENT | GKP | INSTRUMENTATION LABORATORY SPA | 200 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Death |