BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1942023 · Received December 30, 2010

    Report

    Report Number
    1823260-2010-07752
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    December 8, 2010
    Report Date
    February 21, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    CUSTOMER ALLEGEDLY RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT ROCHE METERS, WITHIN 10 MINUTES: 223 MG/DL (INFORM (B)(4)) AND 83 MG/DL (INFORM (B)(4)) PATIENT WAS FEELING HYPOGLYCEMIC AT THE TIME AND WAS EATING LUNCH; THEREFORE, AT THE TIME THE PATIENT WAS NOT TREATED UNTIL AFTER THE LABORATORY READING OF 38 MG/DL. PATIENT WAS GIVEN 2 GLASSES OF JUICE. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 551354

    Patients

    Seq Age Sex Outcome Treatment
    1