BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1062375 · Received June 18, 2008

    Report

    Report Number
    1823260-2008-04828
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    June 7, 2008
    Report Date
    June 18, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS: "LO" (LESS THAN 10 MG/DL), 374 MG/DL, 23 MG/DL AND 91 MG/DL. THE AFOREMENTIONED RESULTS WERE OBTAINED WITHIN 10 MINUTE TIMEFRAMES. NO REPORTED ACTIONS TAKEN. NO ADVERSE EVENT REPORTED. NEW SYSTEM SENT TO CUSTOMER AND RETURN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 550086

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR HUMULIN 70/30 50 UNITS/DAY - 10-15 YEARS| ZETIA 10 MG/DAY - 6 YEARS| "WILCAL" 3840 MG/DAY - 6 YEARS| TRICOR UNK DOSE - 1 TAB/DAY - 6 YEARS| BABY ASPIRIN 162 MG/DAY - 6 YEARS| ALTACE UNK DOSE - 1 TAB/DAY - 6 YEARS