BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1210262 · Received October 22, 2008

    Report

    Report Number
    2183996-2008-01622
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 14, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED AN ELEVATED BLOOD GLUCOSE READING OF 248 MG/DL. SHE STATED SHE WAS USING THE SCROLL METHOD TO GIVE HERSELF A MEAL BOLUS THROUGH HER INSULIN INFUSION DEVICE AND FORGOT TO PRESS THE CHECK KEY AFTER PROGRAMMING THE BOLUS. SHE STATED SHE FELT THIRSTY AND FOUND THE ELEVATED READING. SHE SAID SHE CHECKED HER DEVICE HISTORY AND DISCOVERED SHE HAD NOT RECEIVED HER MEAL BOLUS. SHE STATED SHE CORRECTED HER READING TO 97 MG/DL BY GIVING HERSELF A 3 UNIT BOLUS. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND WILL BE RETURNED FOR EVAL, DUE TO A DEFECTIVE BUTTON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG DISETRONIC MEDICAL SYSTEMS NA NA

    Patients

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