BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2820294 · Received October 31, 2012

    Report

    Report Number
    2183996-2012-01671
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 25, 2012
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, CLINICAL SPECIALIST (CS) REPORTED THE RUBBER ON THE UP BUTTON OF THE INFUSION DEVICE IS BEGINNING TO TEAR OFF. CS STATED THE UP BUTTON IS NOT WORKING CORRECTLY DUE TO THE RUBBER TEARING. ON FOLLOW UP CALL ON (B)(6) 2012, PATIENT REPORTED THE UP BUTTON ON THE INFUSION DEVICE IS FLAT. PATIENT STATED THE BUTTON DOES NOT ALWAYS MAKE AN AUDIBLE CLICK. PATIENT REPORTED THE BUTTON ON THE INFUSION DEVICE DOES WORK BETTER SOMETIMES WHEN THE BUTTON IS PRESSED HARD. PATIENT STATED THE ISSUE BEGAN OCCURRING ABOUT 3 WEEKS AGO. PATIENT REPORTED ONLY HAVING CONCERN WITH THE UP BUTTON. 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 INFUSION DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR INSULIN| INSULIN INFUSION PUMP| RELATED ACCESSORIES