ACL 2000/ANTI-THROMBIN III 106

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report Number67955-1996-09001
MDR Report Key32178
Date Received1996-03-04
Date of Report1996-02-27
Date Facility Aware1996-02-23
Report Date1996-02-27
Date Reported to Mfgr1996-02-27
Date Added to Maude1996-04-25
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameACL 2000/ANTI-THROMBIN III
Generic NameCOAGULATION INSTRUMENTATION & REAGENTS
Product CodeJPE
Date Received1996-03-04
Model Number106
Lot Number951016
OperatorOTHER
Device Availability*
Device AgeNO INFO
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key33426
ManufacturerINSTRUMENTATION LABORATORIES
Manufacturer Address101 HARTWELL AVE LEXINGTON MA 02173 US


Patients

Patient NumberTreatmentOutcomeDate
101. Death 1996-03-04

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