BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1830439 · Received September 2, 2010

    Report

    Report Number
    2183996-2010-01804
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    August 20, 2010
    Report Date
    August 20, 2010
    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
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT REPORTED NONE OF THE BUTTONS ON HER INFUSION DEVICE ARE FUNCTIONING TONIGHT. PT STATED SHE FIRST NOTICED THE UP/DOWN BUTTONS WERE NOT WORKING WHEN SHE WAS UNABLE TO PROGRAM A BOLUS. PT REPORTED SHE THEN NOTICED THE CHECK AND MENU BUTTONS WERE NOT WORKING. PT STATED THE BUTTONS DO NOT APPEAR TO BE FLAT AND THEY POP BACK UP WHEN 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 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 46 YR INSULIN| INSULIN INFUSION SET