BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 3210728 · Received July 8, 2013

    Report

    Report Number
    1823260-2013-04079
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 4, 2013
    Report Date
    September 25, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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

    CALLER REPORTED ADVANTAGE SYSTEM BLOOD GLUCOSE RESULTS, ALL MG/DL, ALL WITHIN 10 MINUTES: 357, 150 80, 62, 64. CUSTOMER STATED THAT HE WAS FEELING SYMPTOMS OF HYPOGLYCEMIA, SO HE DRANK ORANGE JUICE, FELT BETTER. NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310499 ACCU-CHEK ® COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 551942

    Patients

    Seq Age Sex Outcome Treatment
    1 061 YR NOVOLOG| LANTUS