BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2161830 · Received July 14, 2011

    Report

    Report Number
    1823260-2011-03734
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 24, 2011
    Report Date
    August 11, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 WHILE USING COMFORT CURVE TEST STRIPS WITHIN 10 MINUTES: 380 MG/DL AND 106 MG/DL, 295 MG/DL AND 122 MG/DL, 195 MG/DL AND 73 MG/DL THE COMPARISONS WERE PERFORMED ON DIFFERENT DATES. CUSTOMER REPORTS TAKING NOVOLIN R BASED ON THE SECOND RESULT OF THE COMPARISON. 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 551511

    Patients

    Seq Age Sex Outcome Treatment
    1 062 YR OMEPRAZOLE "SA"| GABAPENTIN| FUROSEMIDE| HYDROCODONE| DOCUSATE "NA"| AMOXICILLIN| LANTUS| NOVOLIN R| SIMVASTATIN| LISINOPRIL| LACTOBACILLUS ACIDOPHILUS| BLOOD PRESSURE MONITOR