BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1890722 · Received November 1, 2010

    Report

    Report Number
    2183996-2010-02200
    Event Type
    Malfunction
    Date Received
    November 1, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 21, 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
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PATIENT REPORTED INFUSION DEVICE WOULD NOT PERFORM PRIME FUNCTION. NO ERROR MESSAGES WERE RECEIVED ON INFUSION DEVICE. TROUBLESHOOTING FOUND CHECK BUTTON WAS NOT RESPONDING CONSISTENTLY. PATIENT REPORTED THIS ISSUE HAD BEEN ONGOING BUT COULD NOT PROVIDE AN EXACT DATE. NO ADDITIONAL INFORMATION WAS PROVIDED. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. FOLLOWUP WAS PROVIDED BY CLINICAL SPECIALIST. CLINICAL SPECIALIST ADVISED SHE WAS UNSURE IF PATIENT PRESSED THE CHECK BUTTON CORRECTLY. CLINICAL SPECIALIST WILL ASSIST WITH SETUP OF REPLACEMENT INFUSION DEVICE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT 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 INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR INSULIN INFUSION SET| INSULIN