BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2112806 · Received April 29, 2011

    Report

    Report Number
    2183996-2011-01299
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 2, 2011
    Report Date
    April 12, 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
    GM
    Reporter Occupation
    UNKNOWN

    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 BUTTONS ON THE INFUSION DEVICE ARE NOT FUNCTIONING PROPERLY. PATIENT ATTEMPTED TO GIVE A BOLUS, BUT THE INFUSION DEVICE WOULD NOT RESPOND. PATIENT CHANGED THE BATTERY, AND THE INFUSION DEVICE POWERED ON AND THEN DISPLAYED AN E8 POWER INTERRUPT ERROR. THE ERROR COULD NOT BE CLEARED DUE TO THE DEFECTIVE BUTTONS. PATIENT ASSUMED THE INFUSION DEVICE WAS DELIVERING INSULIN AS INTENDED, AND BLOOD GLUCOSE LEVEL WAS 162 MG/DL DURING THE REPORT. PATIENT ALSO REPORTED THE INFUSION DEVICE IS TURNING OFF. INFUSION DEVICE WAS REQUESTED FOR EVALUATION. THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. ADDITIONAL DETAILS WERE 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 INSULIN INFUSION SET| INSULIN