BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION QID

    MDR report key: 642173 · Received October 19, 2005

    Report

    Report Number
    2954323-2005-00582
    Event Type
    Malfunction
    Date Received
    October 19, 2005
    Date of Event
    September 25, 2005
    Report Date
    October 19, 2005
    Manufacturer
    ABBOTT DIABETES CARE
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS RECEIVING ERRATIC READINGS. IN BLOOD GLUCOSE TESTS, CUSTOMER RECEIVED READINGS OF 434, 114, 123, 234, 124 AND 178 MG/DL WITHIN 10 MINUTES. ALL TESTS WERE PERFORMED ON THE FINGER. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION QID BLOOD GLUCOSE MELTER NBW ABBOTT DIABETES CARE NA 94695

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN