BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2141023 · Received June 16, 2011

    Report

    Report Number
    2183996-2011-01622
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 19, 2011
    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
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    FATHER REPORTED, THE CHECK BUTTON ON THE INFUSION DEVICE IS DEFECTIVE, AND THIS CONCERN HAD BEEN ONGOING FOR 2 WEEKS. THE INFUSION DEVICE OCCASIONALLY "TICKS" ON ITS OWN AND THE DISPLAY SWITCHES BETWEEN INSULIN UNITS PER HOUR, QUICK INFO, AND BOLUS DATA. THE OTHER BUTTONS ON THE INFUSION DEVICE DO NOT FUNCTION WHEN THIS HAPPENS. CORRECT TYPE OF BATTERY IS USED, AND THE BATTERY IS REMOVED AND REINSERTED TO RESOLVE THE ISSUE. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. ADDITIONAL INFO WAS NOT PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR INSULIN| INSULIN INFUSION SET