BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2253734 · Received August 10, 2011

    Report

    Report Number
    2183996-2011-02163
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 27, 2011
    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
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT'S DAUGHTER-IN-LAW REPORTED THE CHECK BUTTON ON THE INFUSION DEVICE IS NOT FUNCTIONING. DAUGHTER-IN-LAW STATED THE BUTTON LOOKS DIFFERENT THAN THE MENU BUTTON. DAUGHTER-IN-LAW REPORTED THE BUTTON LOOKS WORN OUT. DAUGHTER-IN-LAW STATED THE BUTTON WILL SOMETIMES MAKE CONNECT BUT OTHER TIMES IT WILL NOT. DAUGHTER-IN-LAW IS UNSURE OF HOW LONG THE ISSUE HAS BEEN OCCURRING. DAUGHTER-IN-LAW REPORTED THE PLASTIC AROUND THE BUTTON IS CRACKED. DAUGHTER-IN-LAW STATED THE PT IS CURRENTLY IN THE HOSP DUE TO A HEART ATTACK. 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 80 YR INSULIN INFUSION SET| INSULIN