BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2803094 · Received October 19, 2012

    Report

    Report Number
    2183996-2012-01613
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Date of Event
    February 16, 2012
    Report Date
    October 18, 2012
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PATIENT REPORTED THE DOWN BUTTON ON THE INFUSION DEVICE DOES NOT FUNCTION AND THE UP BUTTON WORKS WITH DIFFICULTIES. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REPLACED AND RETURNED FOR EVALUATION. A PRELIMINARY EVALUATION REVEALED THE UP AND DOWN BUTTONS DO NOT FUNCTION. THERE IS AN INTERRUPTION BETWEEN THE PRINTED CIRCUIT BOARD AND THE BUTTONS. ADDITIONAL INFORMATION WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT LZG ROCHE INSULIN DELIVERY SYSTEMS INC. 00700006862 NA

    Patients

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