BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXAC TECH

    MDR report key: 40602 · Received September 11, 1996

    Report

    Report Number
    1220459-1996-00006
    Event Type
    Malfunction
    Date Received
    September 11, 1996
    Date of Event
    August 6, 1996
    Report Date
    August 6, 1996
    Manufacturer
    MEDISENSE, INC.
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ROUTINE COMPLAINT INVESTIGATION CONFIRMS SEVERAL TEST RESULTS OUT-OF-RANGE WITH QUALITY CONTROL SOLUTION RANGES (INTENDED TO VERIFY DEVICE PERFORMANCE). HAD THESE RESULTS BEEN OBTAINED FROM A PT SAMPLE, COULD POTENTIALLY HAVE HAD AN ADVERSE EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXAC TECH BLOOD GLUCOSE MONITORING SYSTEM CFR MEDISENSE, INC. NA 42220

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Disability