BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2210199 · Received July 8, 2011

    Report

    Report Number
    2183996-2011-01990
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 30, 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

    CUSTOMER REPORTED THE MENU BUTTON IS DEFECTIVE ON A DEMONSTRATION INFUSION DEVICE. THE MENU BUTTON HAS TO BE PRESSED HARD FOR THE INFUSION DEVICE TO RESPOND, AND SOMETIMES THE BUTTON DOES NOT WORK AT ALL. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AS THIS INFUSION DEVICE WAS NEVER USED BY A PATIENT. INFUSION DEVICE WAS REQUESTED FOR EVALUATION. NO ADDITIONAL INFORMATION WAS 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