BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2894625 · Received January 3, 2013

    Report

    Report Number
    1823260-2013-00045
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    November 28, 2012
    Report Date
    February 1, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    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 THE ADVANTAGE SYSTEM WITHIN 10 MINUTES: 1. 46 MG/DL AND 252 MG/DL - WITHIN 1 MINUTE 2. 252 MG/DL, 79 MG/DL, AND 323 MG/DL - WITHIN 2 MINUTES 3. 77 MG/DL AND 166 MG/DL - WITHIN 1 MINUTE SETS OF READINGS WERE TAKEN ON DIFFERENT DAYS. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2915 ACCU-CHEK ® COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 551785

    Patients

    Seq Age Sex Outcome Treatment
    1 058 YR ATORVASTATIN| ENALAPRIL| JANUVIA| LEVEMIR| OMEPRAZOLE| AMITRIPTYLINE| METFORMIN