BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2172366 · Received June 17, 2011

    Report

    Report Number
    2183996-2011-01797
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    March 31, 2011
    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
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED HE HAS BEEN HAVING ISSUE WITH IS UP AND DOWN ARROW BUTTONS ON THE INFUSION DEVICE. PT STATED THE DOWN ARROW BUTTON HASN'T BEEN WORKING FOR THE PAST 2 MONTHS. PT REPORTED THE UP ARROW BUTTON WAS INTERMITTENT. PT STATED NOW THE DOWN ARROW BUTTON AND THE UP ARROW BUTTON BOTH DON'T WORK. PT IS CURRENTLY ON HIS BACKUP INFUSION DEVICE. PT REPORTED HE NOTICED THE ISSUES WHEN HE WAS ATTEMPTING TO BOLUS. PT STATED THE BUTTONS POP BACK OUT. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT 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 EVAL.

    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 32 YR INSULIN| INSULIN INFUSION SET