BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLASH

    MDR report key: 1809446 · Received July 19, 2007

    Report

    Report Number
    2954323-2007-13056
    Event Type
    Malfunction
    Date Received
    July 19, 2007
    Date of Event
    June 18, 2007
    Report Date
    July 19, 2007
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S METER ((B)(4)) AND STRIPS (072225) WERE RETURNED AND PRODUCT TESTING DID NOT CONFIRM THE CUSTOMER'S COMPLAINT. ALL RESULTS WERE WITHIN RANGE SPECIFICATIONS AND NO ERRORS WERE NOTED DURING CONTROL SOLUTION TESTING. ONLY THREE OF THE READINGS REPORTED BY THE CUSTOMER WERE PRESENT IN THE METER'S MEMORY LOG, OF WHICH ONLY TWO 80 MG/DL AND 180 MG/DL WERE TAKEN WITHIN TEN MINUTES. THE CUSTOMER ALSO REPORTS AN INCIDENT WHICH OCCURRED ON (B)(6) 2007 IN THE MORNING WHERE THEY ADMINISTERED INSULIN (THE CUSTOMER REPORTS BEING ON AN INSULIN PUMP) AND THEN FELL OUT OF BED AND LOST CONSCIOUSNESS. THE CUSTOMER REPORTS CALLING THE PARAMEDICS AND ADMINISTERING ORANGE JUICE TO COUNTERACT THE MEDICAL EVENT. BASED ON THE READINGS IN THE METER'S MEMORY LOG FOR THE (B)(6), THE SYMPTOMS REPORTED ARE CONSISTENT WITH THE ADC METER'S READING OF 33 MG/DL.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING IMPRECISE METER READINGS ON HIS FREESTYLE FLASH BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS ON 139MG/DL AND 401MG/DL 80MG/DL, AND 180MG/DL WITHIN 10 MINUTES. ALL TESTS WERE PERFORMED ON THE FINGER. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FLASH BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC, USA NI 072225

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other