BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION QID

    MDR report key: 1010455 · Received May 11, 2007

    Report

    Report Number
    2954323-2007-07704
    Event Type
    Malfunction
    Date Received
    May 11, 2007
    Date of Event
    April 11, 2007
    Report Date
    May 11, 2007
    Manufacturer
    ABBOTT DIABETES CARE LIMITED UK
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RECEIVED AND TESTING COULD NOT DUPLICATE CUSTOMER'S COMPLAINT. ALL RESULTS WERE WITHIN RANGE SPECIFICATIONS AND NO NEW ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. REPORTABLE AS THE READINGS REPORTED ARE CONSIDERED CLINICALLY SIGNIFICANT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A COMPLAINT OF IMPRECISE READINGS ON THEIR PRECISION QID BLOOD GLUCOSE METER. THE CUSTOMER OBTAINED READINGS OF 130 MG/DL ON THEIR METER COMPAIRED WITH A LAB RESULTS OF 70 MG/DL. BOTH COMPARISONS WERE TAKEN WITHIN A TEN MINUTE TIMEFRAME. WHEN PLOTTED ON A PARKES ERROR GRID THE RESULTS FALL IN THE 'C' ZONE, WHICH SHOWS THE DIFFERENCE TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION QID BLOOD GLUCOSE METER NBW ABBOTT DIABETES CARE LIMITED UK NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI