BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT DIABETES CARE

    MDR report key: 1951938 · Received January 3, 2011

    Report

    Report Number
    MW5018868
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    December 31, 2010
    Report Date
    January 3, 2011
    Manufacturer
    ABBOTT DIABETES CARE
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    GRIEVOUS MISHANDLING OF ABBOTT DIABETES CARE URGENT PRODUCT RECALL. FIRST REPORT TO ABBOTT INSISTED I MUST DO A FIELD EXCHANGE. SECOND REPORT PERMITTED REPLACEMENT BY (B)(6) OR (B)(6), AS I ORIGINALLY REQUESTED. DIAGNOSIS OR REASON FOR USE: PRE-DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT DIABETES CARE BLOOD GLUCOSE TEST STRIPS LFR ABBOTT DIABETES CARE 45001 A709

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR