BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCEL BLOOD GLUCOSE STRIPS

    MDR report key: 358950 · Received October 19, 2001

    Report

    Report Number
    MW4003126
    Event Type
    Malfunction
    Date Received
    October 19, 2001
    Report Date
    September 20, 2001
    Manufacturer
    *
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    RPTR IS WRITING OUT OF CONCERN ABOUT A LETTER THEY RECENTLY RECEIVED FROM A DISTRIBUTOR. THIS DISTRIBUTOR SENT RPTR A LETTER REGARDING EXCEL BLOOD GLUCOSE STRIPS RECALLED DUE TO FILL PROBLEMS. PART OF RPTR'S PROBLEM WITH THIS RECALL IS THAT THEY WERE INFORMED FROM A DISTRIBUTOR RATHER THAN THE MFR. RPTR THEN WENT DIRECTLY TO THE FDA ENFORCEMENT WEBSITE TO SEE THE EXTEND OF THE PROBLEM, BUT FOUND NOTHING. RPTR LOOKS FORWARD TO SEEING AN UPDATE ABOUT THIS PRODUCT ON THE FDA ENFORCEMENT WEBSITE. RPTR FEELS IT IS IMPORTANT TO INFORM HEALTH CARE PROFESSIONALS OF THIS TYPE OF INFO IN A TIMELY MANNER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47524 EXCEL BLOOD GLUCOSE STRIPS BLOOD GLUCOSE STRIPS CFR * NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA