BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2022629 · Received March 17, 2011

    Report

    Report Number
    1823260-2011-01479
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 17, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON ADVANTAGE SYSTEM WITHIN 10 MINUTES WHILE USING COMFORT CURVE TEST STRIPS: 45 MG/DL, 181 MG/DL, 41 OR 42 MG/DL AND 219 MG/DL. LOW BLOOD GLUCOSE SYMPTOMS WERE REPORTED WITH THESE RESULTS. CUSTOMER SELF TREATED WITH ORANGE JUICE AND GRAHAM CRACKERS. NO ADVERSE EVENT RELATED TO THE DEVICE WAS 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 072 YR LANTUS| BLOOD PRESSURE CUFF TWICE DAILY| NOVOLOG BEFORE MEALS