BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2803120 · Received October 19, 2012

    Report

    Report Number
    2183996-2012-01614
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 16, 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
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, PT REPORTED THE INFUSION DEVICE WAS "FROZEN" AND THE BUTTONS WOULD NOT RESPOND TO PRESS. THE INFUSION DEVICE DOES NOT RESPOND EVEN IF THE BUTTONS ARE PRESSED HARD, AND THE PROTECTIVE RUBBER ON THE UP AND DOWN BUTTONS HAS COME OFF. THE INFUSION DEVICE WAS NOT DROPPED ON A HARD SURFACE. HE SWITCHED TO HIS BACKUP INFUSION DEVICE AND WAS UNABLE TO PROVIDE ADDITIONAL DETAILS REGARDING THE ALLEGATION. THE INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND HE DID NOT REQUIRE TREATMENT FROM 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 49 YR INSULIN| RELATED ACCESSORIES| INSULIN INFUSION PUMP