BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE TEST STRIPS

    MDR report key: 1419421 · Received July 20, 2009

    Report

    Report Number
    MW5012068
    Event Type
    Malfunction
    Date Received
    July 20, 2009
    Date of Event
    July 15, 2009
    Report Date
    July 20, 2009
    Manufacturer
    ABBOTT DIABETES
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED FREESTYLE LITE TEST STRIPS. LOT: 0901629 EXP: 2011/01. SHE REPORTED THE STRIPS DID NOT WORK. THEY WOULD NOT TURN ON HER METER AND IF THE METER DID TURN ON, AFTER SHE APPLIED HER SAMPLE OF BLOOD, IT WOULD NOT BE READ BY THE MACHINE. SHE BROUGHT THE STRIPS INTO THE PHARMACY AND INDEED, THEY DID NOT EVEN TURN ON THE METER. I REPLACED HER STRIPS AND THE NEW ONES TURNED HER METER ON AND PROVIDED A BLOOD GLUCOSE READING. DOSE OR AMOUNT: TEST 12 TIMES A DAY X 1 WEEK. DATES OF USE: 2009. DIAGNOSIS OR REASON FOR USE: DIABETES MELLITUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE TEST STRIPS FREESTYLE LITE TEST STRIPS LFR ABBOTT DIABETES 0901629

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR