BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2803119 · Received October 19, 2012

    Report

    Report Number
    2183996-2012-01615
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Date of Event
    September 19, 2012
    Report Date
    October 10, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, COMPANY REPRESENTATIVE REPORTED THE UP AND DOWN BUTTONS ON THE INFUSION DEVICE ARE DEFECTIVE. FOLLOW-UP WAS COMPLETED WITH THE PT, AND HE REPORTED THE UP BUTTONS DOES NOT FUNCTION CORRECTLY. THIS HAS OCCURRED FOR THE PAST 2-3 WEEKS WHEN HE TRIES TO PROGRAM A BOLUS. HE PROGRAMMED A STANDARD BOLUS DURING TROUBLESHOOTING. WHEN HE HELD THE UP BUTTON, THE INFUSION DEVICE WOULD "GO UP A FEW NUMBERS THEN STOP." PT REPORTED HE MAINTAINED PRESSURE ON THE BUTTON, AND THE BUTTON IS SOMEWHAT FLAT. THE BUTTON DOES MAKE AN AUDIBLE CLICK WHEN PRESSED. THE INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND HE DID NOT REQUIRE TREATMENT FORM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    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 72 YR RELATED ACCESSORIES| INSULIN INFUSION PUMP| INSULIN