BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1913965 · Received November 19, 2010

    Report

    Report Number
    2183996-2010-02389
    Event Type
    Malfunction
    Date Received
    November 19, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 14, 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
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT REPORTED HER INFUSION DEVICE GET WET WITH RAIN, AND THEN THE BOTTOM PART OF THE DISPLAY SCREEN WOULD NOT DISPLAY ANYTHING. SHE CONTINUED TO USE THE INFUSION DEVICE AND HOPED IT WOULD DRY. INFUSION DEVICE WAS NOT SUBMERGED IN WATER BUT DID GET "PRETTY WET" FROM RAIN. THERE WAS NO VISIBLE DAMAGE TO DISPLAY OR MOISTURE OR WATER BEHIND THE SCREEN. CORRECT TYPE OF BATTERY WAS BEING USED IN INFUSION DEVICE. PT INSERTED A NEW BATTERY AND THE INFUSION DEVICE STARTED AS NORMAL. PT NOTICED A HORIZONTAL BLACK LINE EXTENDING FROM ONE END OF THE DISPLAY TO THE OTHER. BLACK LINE DID NOT APPEAR UNTIL BATTERY CHANGE, BUT SHE COULD THEN SEE THE BOTTOM HALF OF THE DISPLAY. PT WAS UNABLE TO SEE BASAL DELIVERY AMOUNT OVER THE PREVIOUS FEW DAYS WHILE WEARING THE INFUSION DEVICE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. INFUSION DEVICE WAS REPLACED AND REQUESTED 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 43 YR INSULIN| INSULIN INFUSION SET