BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2803137 · Received October 19, 2012

    Report

    Report Number
    2183996-2012-01626
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Date of Event
    September 14, 2012
    Report Date
    October 14, 2012
    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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012 PT REPORTED RECEIVING A REOCCURRING E2 (BATTERY DEPLETED) ERROR MESSAGE. PT STATED HE PURCHASED A NEW BATTERY AND WANTED TO CALL PRIOR TO INSERTING IT INTO THE INFUSION DEVICE. PT REPORTED INSERTING THE NEW BATTERY AND PLACED THE INFUSION DEVICE IN THE RUN MODE WITHOUT DUPLICATING THE ERROR MESSAGE. PT STATED THIS HAS OCCURRED MULTIPLE TIMES WITHIN THE PAST FEW MONTHS. ADVISED PT TO CHECK THE ALARM HISTORY. PT REPORTED MULTIPLE E2 ERROR MESSAGES BUT NEVER RECEIVED AN A2 (LOW BATTERY) ALERT PRIOR TO RECEIVING THE ERROR MESSAGE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR RELATED ACCESSORIES| INSULIN INFUSION PUMP| INSULIN