BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1890711 · Received November 1, 2010

    Report

    Report Number
    2183996-2010-02163
    Event Type
    Malfunction
    Date Received
    November 1, 2010
    Date of Event
    August 20, 2010
    Report Date
    October 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 Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT REPORTED THERE IS A PART OF THE DISPLAY SCREEN ON HER INFUSION DEVICE THAT IS RIGHT OF THE BASAL RATE ICON WHERE THERE ARE WHAT SHE DESCRIBED AS "SCRIBBLES ON THE SCREEN." PT STATED SHE CAN SEE HER CURRENT BASAL RATES AND BOLUS AMOUNTS BUT WHEN SHE CHECKS THE MEMORY, SHE CAN BARELY MAKE OUT THE CHARACTERS. PT REPORTED SHE TYPICALLY CANNOT READ THE MEMORY. PT STATED SHE HAS TRIED REPLACING THE BATTERY SEVERAL TIMES AND THE ISSUE PERSISTS. PT REPORTED THE ISSUE FIRST OCCURRED ABOUT 2 MONTHS AGO. 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 EVAL.

    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 48 YR INSULIN| INSULIN INFUSION SET