BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2081469 · Received April 12, 2011

    Report

    Report Number
    2183996-2011-00974
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 15, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    Z-1415-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PATIENT REPORTED, THE UP AND DOWN BUTTONS ON THE INFUSION DEVICE WERE DEFECTIVE. THIS WAS NOTICED ON THE DAY OF REPORT WHEN PATIENT BOLUSED. PATIENT PRESSED THE UP BUTTON, AND IT DID BEEP. PATIENT WAS NOT ABLE TO VERIFY WHAT WAS ON THE SCREEN DUE TO VISION CONCERNS. PATIENT HAS USED THIS INFUSION DEVICE FOR 4 YEARS AND BOLUSES 4-5 TIMES PER DAY. THE BUTTONS POP UP AFTER THEY ARE PRESSED. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    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 72 YR INSULIN INFUSION SET| INSULIN