BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2211332 · Received August 15, 2011

    Report

    Report Number
    1823260-2011-04349
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 25, 2011
    Report Date
    September 28, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT A PATIENT REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE ADVANTAGE SYSTEM WITHIN 10 MINUTES: HI (GREATER THAN 600 MG/DL), 173 MG/DL, AND HI (GREATER THAN 600 MG/DL). CUSTOMER STATES THAT THE PATIENT HAD SYMPTOMS OF HIGH BLOOD SUGAR AT THE TIME OF THE READINGS. CUSTOMER THINKS THAT THE READING OF 173 MG/DL WAS DUE TO AN UNDERDOSED STRIP. DUE TO THE MEDICAL NEED OF THE PATIENT, HE WAS AIRLIFTED IMMEDIATELY FROM THE OIL RIG TO THE HOSPITAL. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. 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 551348

    Patients

    Seq Age Sex Outcome Treatment
    1