BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1964557 · Received December 22, 2010

    Report

    Report Number
    2183996-2010-02673
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 17, 2010
    Report Date
    December 17, 2010
    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
    OK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT REPORTED THE BUTTON ON THE SIDE OF THE INFUSION DEVICE IS NOT ALWAYS RESPONDING. VERIFIED IT IS THE DOWN BUTTON THAT IS GIVING THE PT ISSUES. PT STATED, THIS IS AN INTERMITTENT ISSUE AND "HE HAS TO GET IT JUST RIGHT" IN ORDER FOR IT TO WORK. PT REPORTED, HE NOTICED THE ISSUE FOR THE FIRST TIME ABOUT A MONTH AGO WHILE ATTEMPTING TO PROGRAM A BOLUS. PT STATED, THE BUTTONS POP BACK UP WHEN PRESSED. ADVISED PT ON HOW TO USE STANDARD BOLUS OPTION IN MENU OPTIONS TO AVOID USING THE DOWN BUTTON UNTIL HE RECEIVES HIS REPLACEMENT DEVICE. 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 64 YR INSULIN INFUSION SET| INSULIN