BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCE-CHEK SPIRIT

    MDR report key: 1855179 · Received September 27, 2010

    Report

    Report Number
    2183996-2010-01964
    Event Type
    Injury
    Date Received
    September 27, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 9, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, COMPANY REPRESENTATIVE REPORTED BOLUSES WERE LISTED IN INFUSION DEVICE HISTORY THAT WERE NOT PROGRAMMED BY PT. PT DID NOT BOLUS AT THE TIMES LISTED AND DID NOT PRESS ANY INFUSION DEVICE BUTTONS. FOLLOW-UP WAS COMPLETED WITH PT. PT REPORTED HE EXPERIENCED HYPOGLYCEMIA ON (B)(6) 2010 WITH READINGS OF 49, 53, AND 50 MG/DL. TARGET BLOOD GLUCOSE IS 150 MG/DL. PT TREATED HIMSELF WITH ORANGE DRINK AND BLOOD GLUCOSE LOWERED AGAIN. THERE WERE 4 BOLUSES IN THE INFUSION DEVICE HISTORY WHICH WERE NOT PROGRAMMED BY PT. ON DAY OF EVENT, THE INSULIN CARTRIDGE WAS NEW. THE BASAL RATES AND TIME WERE PROGRAMMED CORRECTLY. PT DID NOT PRIME OR REMOVE THE INSULIN CARTRIDGE WHILE THE INFUSION TUBING WAS CONNECTED TO HIS BODY. INFUSION DEVICE WAS NOT DROPPED OR EXPOSED TO MOISTURE OR LIQUID. NO CHARGES WERE REPORTED TO DIET, MEDICATION, OR LIFESTYLE. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL. THE PT 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 ACCE-CHEK SPIRIT INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention INSULIN| INSULIN INFUSION SET