BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 1873561 · Received October 11, 2010

    Report

    Report Number
    2183996-2010-02116
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    September 28, 2010
    Report Date
    October 3, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PT REPORTED THE BLACK PLUNGER OF THE INFUSION DEVICE PISTON ROD WAS CROOKED AND THE INSULIN CARTRIDGE WAS WET. THE BLACK PLUNGER OF THE PISTON ROD APPEARED CROOKED WHILE INFUSION DEVICE WAS IN USE. AFTER INSULIN CARTRIDGE WAS REMOVED, THE BLACK PLUNGER APPEARED STRAIGHT. PT BELIEVES INSULIN DELIVERY OF THE INFUSION DEVICE IS INACCURATE. PT EXPERIENCED HIGH BLOOD GLUCOSE OF 300 MG/DL AND DELIVERED CORRECTION INSULIN BY INFUSION DEVICE AND PEN. PT CHANGES INFUSION SET EVERY 2 DAYS AND TRANSFER SET EVERY 4 DAYS. TARGET BLOOD GLUCOSE IS 80-140 MG/DL. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. INFUSION DEVICE WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention INSULIN INFUSION SET| INSULIN