BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2231661 · Received July 22, 2011

    Report

    Report Number
    2183996-2011-02079
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 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
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED THE INFUSION DEVICE DISPLAYED E2 BATTERY DEPLETED ERROR W/O PROVIDING AN A2 LOW BATTERY ALERT FIRST. BATTERY SETTING WAS PROGRAMMED CORRECTLY ON THE INFUSION DEVICE, AND THE CORRECT TYPE OF BATTERY WAS USED. IT WAS VERIFIED IN THE ALARM HISTORY THAT AN A2 LOW BATTERY ALERT WAS NOT GIVEN. INFUSION DEVICE WAS NOT DROPPED IN THE PAST 48 HRS. PT WAS UNABLE TO CLEAR THE E2 BATTERY DEPLETED ERROR. INFUSION DEVICE, BATTERY, AND BATTERY COVER WERE REQUESTED FOR EVAL. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. PT 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 12 YR INSULIN INFUSION SET| INSULIN