BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2010159 · Received March 1, 2011

    Report

    Report Number
    2183996-2011-00346
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    August 15, 2010
    Report Date
    February 15, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PATIENT REPORTED THE INFUSION DEVICE DISPLAY HAS MISSING SEGMENTS. THIS WAS FIRST NOTICED 6 MONTHS PRIOR TO THE REPORT. THE MISSING SEGMENTS ARE LOCATED WHERE THE BASAL RATE IS DISPLAYED IN THE MIDDLE OF THE SCREEN. HE HAS CHANGED THE BATTERY SEVERAL TIMES, BUT THE ISSUE PERSISTS. THE INFUSION DEVICE WAS NOT DROPPED OR DAMAGED. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR INSULIN| INSULIN INFUSION SET