BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 1872028 · Received October 8, 2010

    Report

    Report Number
    2183996-2010-02090
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 28, 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

    MOTHER REPORTED THE INFUSION DEVICE DID NOT PROVIDE W1 LOW CARTRIDGE WARNING BEFORE THE E1 CARTRIDGE EMPTY ERROR. THIS OCCURRED WITH 4 INSULIN CARTRIDGES OVER THE PREVIOUS 3 WEEKS. BACKLIGHT OF INFUSION DEVICE IS ALSO DEFECTIVE. BLOOD GLUCOSE ELEVATED TO 250 MG/DL AS A RESULT. PATIENT CHANGED INSULIN CARTRIDGE AND INFUSION SET AND DELIVERED A CORRECTION BOLUS BY THE INFUSION DEVICE. PATIENT DID SPILL KETONES. PATIENT CHANGES INFUSION HEADSET EVERY 2 DAYS AND TUBING AND INSULIN CARTRIDGE EVERY 5 DAYS. CORRECT TYPE OF BATTERIES ARE USED IN INFUSION DEVICE. INFUSION DEVICE WAS NOT EXPOSED TO WATER OR ELECTROMAGNETIC FIELDS. TARGET BLOOD GLUCOSE IS 110-130 MG/DL. PATIENT DID NOT LOSE CONSCIOUSNESS OR REQUIRE HOSPITALIZATION. THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    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 Required Intervention INSULIN INFUSION SET| INSULIN