BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1840414 · Received September 21, 2010

    Report

    Report Number
    1823260-2010-05609
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    September 4, 2010
    Report Date
    September 24, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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

    IT WAS REPORTING THAT THE INSULIN PUMP HAD UNRESPONSIVE BUTTONS. TROUBLESHOOTING WAS PERFORMED. THE DEVICE RESTED AND IT HAD FROZEN DISPLAY. NO FURTHER INFO WAS PROVIDED.

    Description of Event or Problem · 1

    CALLER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON AN ADVANTAGE METER, COMPARED TO A PROFESSIONAL METER, WITHIN 10 MINUTES: 80 MG/DL (ADVANTAGE) AND 20 MG/DL (PARAMEDIC'S METER). CUSTOMER WAS TREATED FOR HYPOGLYCEMIA WITH AN IV OF UNKNOWN CONTENTS BY THE PARAMEDICS. CUSTOMER WAS NOT TRANSPORTED TO THE HOSPITAL. 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 551065

    Patients

    Seq Age Sex Outcome Treatment
    1 069 YR Required Intervention