BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2840103 · Received November 20, 2012

    Report

    Report Number
    1823260-2012-05866
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 22, 2012
    Report Date
    January 7, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. WILL NOT BE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE ADVANTAGE SYSTEM WITHIN 10 MINUTES: 500 MG/DL, 367 MG/DL, AND 225 MG/DL. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS; HOWEVER, CUSTOMER DOES NOT HAVE STRIPS TO RETURN. 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
    1 081 YR HUMULIN N| VITAMIN D-3| ATENOLOL| ALLOPURINOL| FUROSEMIDE| SIMVASTATIN| CALCITRIOL| ASPIRIN| HUMULIN 70/30| AMLODIPINE BESYLATE