BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2141004 · Received June 16, 2011

    Report

    Report Number
    2183996-2011-01612
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    April 4, 2011
    Report Date
    May 19, 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
    MS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PATIENT'S WIFE REPORTED BOTH BUTTONS ON THE INFUSION DEVICE HAVE NOT BEEN FUNCTIONING. WIFE STATED, THE PATIENT NOTICED THE ISSUE IN THE LAST MONTH AND A HALF. WIFE REPORTED, THE BUTTONS DO POP BACK UP WHEN PRESSED. 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 SUSPECT 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 59 YR INSULIN INFUSION SET| INSULIN