BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISIONPOINT OF CARE BLOOD GLUCOSE TESTS STRIPS

    MDR report key: 1950596 · Received December 28, 2010

    Report

    Report Number
    MW5018757
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Report Date
    December 28, 2010
    Manufacturer
    ABBOTT DIABETES CARE, LTD.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FACILITY IS NOT AFFECTED. ONE BOX IN STOCK, UNOPENED. REMOVED FROM SUPPLY. ABBOTT GLUCOSE TEST STRIPS RECALL: DUE TO FALSE LOW BLOOD GLUCOSE RESULTS. DIAGNOSIS OR REASON FOR USE: DIABETES. PRECISION XTRA, PRECISION XCEED: 1 BOX AFFECTED: UNOPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISIONPOINT OF CARE BLOOD GLUCOSE TESTS STRIPS PRECISION XTRA, PRECISION XCEED NBW ABBOTT DIABETES CARE, LTD. 45515

    Patients

    Seq Age Sex Outcome Treatment
    1