BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2172430 · Received June 17, 2011

    Report

    Report Number
    2183996-2011-01812
    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
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PATIENT REPORTED HAVING CONCERNS WITH THE UP BUTTON ON THE INFUSION DEVICE. PATIENT STATED THE UP BUTTON IS NOT RESPONDING ALL OF THE TIME. PATIENT REPORTED SHE WILL ATTEMPT TO PROGRAM A BOLUS, BUT THE UP BUTTON DOES NOT RESPOND WITH EVERY PRESS. PATIENT STATED THE BUTTONS FEEL "MUSHY." PATIENT REPORTED SHE FIRST NOTICED THE ISSUE ABOUT 6 MONTHS AGO. PATIENT STATED THE BUTTONS DO NOT FEEL LIKE THEY USED TO. 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 50 YR INSULIN INFUSION SET| INSULIN