BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1061645 · Received June 17, 2008

    Report

    Report Number
    2183996-2008-00872
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    May 29, 2008
    Report Date
    May 29, 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

    Description of Event or Problem · 1

    THE PT REPORTED THE BATTERY COVER ON HER INSULIN INFUSION DEVICE IS STUCK DUE TO HER USING A COIN TO REMOVE THE BATTERY COVER. SHE STATED SHE LOST HER BATTERY TOOL AND THE COVER IS STRIPPED. SHE SAID SHE WOKE UP THIS MORNING WITH HER DEVICE GIVING A LOW BATTERY MESSAGE AND WAS UNABLE TO CHANGE THE BATTERY. SHE STATED SHE HAD AN ELEVATED BLOOD GLUCOSE READING OF 379 MG/DL WITH HER NORMAL RANGE BEING 70-160 MG/DL. SYMPTOMS WERE EXTREME THIRST AND AGGRAVATION AND SHE TREATED HER READING BY INJECTING INSULIN. THE PT WAS ASSISTED IN SETTING UP HER BACKUP INFUSION DEVICE. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVAL.

    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