BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2112216 · Received April 29, 2011

    Report

    Report Number
    2183996-2011-01293
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 15, 2011
    Report Date
    April 8, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PATIENT REPORTED, THE RUBBER AROUND THE UP BUTTON ON THE INFUSION DEVICE IS FALLING OFF. PATIENT STATED IT IS REQUIRING THAT HE PRESS THE UP BUTTON TWICE TO GET IT TO RESPOND. PATIENT REPORTED, THE UP BUTTON IS ERRATIC IN RESPONDING BECAUSE THE RUBBER OF THE BUTTON HAS FALLEN OFF. PATIENT STATED, THE ISSUE IS EXPOSING THE METAL OF THE BUTTON AND THE BUTTON ITSELF IS LOOSE AND WIGGLES AROUND. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR INSULIN| INSULIN INFUSION SET