BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASTTAKE

    MDR report key: 409359 · Received August 2, 2002

    Report

    Report Number
    2939301-2002-08439
    Event Type
    Malfunction
    Date Received
    August 2, 2002
    Report Date
    July 26, 2002
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CALLED LFS ON 7/2002 ALLEGING THAT THE TEST STRIPS HAD EXTRA LONG CONTACT BARS. AND EXPLAINED THAT WHEN TEST STRIP FROM ONE PARTICULAR VIAL WERE INSERTED INTO THE METER, THE CONTACT BARS STUCK OUT MORE FROM THE TEST STRIP PORT THAN THE PREVIOUS TEST STRIPS. DID NOT REPORT ANY SYMPTOMS, HOWEVER, CUSTOMER DID EXPLAIN THAT UPON OPENING THIS NEW VIAL OF STRIPS, THE BLOOD GLUCOSE LEVELS WERE "25 POINTS" HIGHER THAN NORMAL AND REPORTED READINGS HIGH SUCH AS "189 MG/DL, 192 MG/DL, AND 196 MG/DL". NO REPORT OF ANY RESULTS FROM PRIOR TEST STRIPS. THE CONTROL SOLUTION TEST PASSED (180: 158-239). CUSTOMER WAS CONCERNED WITH THE VARIATION BETWEEN DIFFERENT CONTROL TEST RESULTS, EVEN THOUGH THEY WERE WITHIN RANGE. THERE WAS NO EVIDENCE THAT THE METER ITSELF MALFUNCTIONED, HOWEVER, THE TEST STRIPS HAD ABNORMALLY LONG CONTACT BARS, WHICH COULD HAVE CAUSED POSSIBLE VARIATIONS IN THE RESULTS. THE "CCR" REPLACED THE TEST STRIPS AND THE METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FASTTAKE BLOOD GLUCOSE MONITORING KIT/SYSTEM CFR LIFESCAN, INC. NA 1016399

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR