BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1002992 · Received February 20, 2008

    Report

    Report Number
    2183996-2008-00173
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    February 5, 2008
    Report Date
    February 5, 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
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE PT REPORTED HE HAS BEEN EXPERIENCING ELEVATED BLOOD GLUCOSE READINGS OF UP TO OVER 500MG/DL. HE REQUESTED ASSISTANCE IN CHECKING HIS BOLUS HISTORY ON HIS INSULIN INFUSION DEVICE. TO TROUBLESHOOT, THE PT WAS INSTRUCTED TO PUT HIS DEVICE IN THE STOP MODE AND CHECK HIS BOLUS HISTORY. HE STATED, "I THINK THIS MORNING I DID SOMETHING WRONG. I USED THE UP/DOWN BUTTONS TO PROGRAM MY BOLUS AND I WASN'T HOLDING IT IN LONG ENOUGH." THE PROPER PROCEDURE TO PROGRAM A QUICK BOLUS WAS REVIEWED WITH THE PT. ON FOLLOW UP WITH THE PT, HE STATED HIS BLOOD GLUCOSE LEVELS ARE WITHIN HIS NORMAL RANGE AND HE HAS CORRECTLY ADMINISTERED HIS BOLUSES. NO PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    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 YR Other| R INSULIN INFUSION SET| INSULIN