BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2932114 · Received January 18, 2013

    Report

    Report Number
    2183996-2013-00058
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 1, 2011
    Report Date
    March 1, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    Z-1646-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFUSION DEVICE WAS EVALUATED, AND THE COMPLAINT WAS VERIFIED. THE DOWN BUTTON DOES NOT OPERATE. THE CONNECTION OF THE FLEX PRINT IS INTERRUPTED.

    Description of Event or Problem · 1

    ON (B)(6) 2013 PT REPORTED THE PT IS HAVING ISSUES WITH THE INFUSION DEVICE. PT STATED THE DOWN BUTTON ON THE INFUSION DEVICE DOES NOT RESPOND. PT REPORTED HE DOES NOT RECALL GETTING THE BUTTON RECALL NOTIFICATION. PT STATED THAT ABOUT LAST WINTER OR SO THE DOWN BUTTON STOPPED RESPONDING. PT REPORTED HE THINKS HE WAS AT HOME WHEN HE NOTICED THE ISSUE. PT STATED HE NOTICED THE ISSUE BECAUSE THE BUTTON WOULD NOT RESPOND DURING PRIMING. PT REPORTED THE BUTTON DOES POP BACK UP WHEN PRESSED AND DOES NOT SEEM FLAT. PT STATED THE FAILURE IS CONSTANT AND THE BUTTON DOES NOT WORK IF IT IS PRESSED HARD. PT REPORTED THE BUTTON DOES MAKE A SOUND WHEN IT IS PRESSED. 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 INFUSION DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28627 ACCU-CHEK SPIRIT LZG ROCHE HEALTH SOLUTIONS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 045 YR INSULIN INFUSION PUMP| INSULIN| RELATED ACCESSORIES