BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2172389 · Received June 17, 2011

    Report

    Report Number
    2183996-2011-01795
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    November 30, 2010
    Report Date
    May 31, 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
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PATIENT REPORTED HIS DOWN ARROW BUTTON ON THE INFUSION DEVICE HASN'T WORKED FOR THE PAST 6 MONTHS OR MAYBE A LITTLE LONGER THAN THAT. PATIENT STATED THE UP ARROW BUTTON WILL ONLY WORK WHEN HE PRESSES IT IN JUST THE RIGHT POSITION. PATIENT REPORTED HE NOTICED THE ISSUE WHEN HE WOULD ATTEMPT TO BOLUS. PATIENT STATED THE BUTTONS DO POP BACK OUT. 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 57 YR INSULIN| INSULIN INFUSION SET