BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2896203 · Received December 7, 2012

    Report

    Report Number
    2183996-2012-01935
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 29, 2012
    Report Date
    November 29, 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
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, PATIENT REPORTED THE BUTTONS ON THE INFUSION DEVICE WOULD NOT RESPOND TO PRESS. SHE REPLACED THE BATTERY, AND THE INFUSION DEVICE DISPLAYED AN E8 POWER INTERRUPT ERROR THAT COULD NOT BE CONFIRMED. THE INFUSION DEVICE WAS NOT DROPPED. THE KEY-LOCK FEATURE IS NOT ACTIVATED. SHE ALSO REPORTED THE PROTECTIVE RUBBER ON THE UP BUTTON FELL OFF "SOME TIME AGO," BUT THE BUTTONS CONTINUED TO FUNCTION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND SHE DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REQUESTED 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 48 YR INSULIN| DATE OF THERAPY: UNK| INSULIN INFUSION PUMP| RELATED ACCESSORIES