BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1030016 · Received April 14, 2008

    Report

    Report Number
    2183996-2008-00522
    Event Type
    Injury
    Date Received
    April 14, 2008
    Date of Event
    April 5, 2008
    Report Date
    April 8, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON 04/08/2008 THE PATIENT'S MOTHER REPORTED THAT THE INFUSION DEVICE FAILED TO A1 WHEN THE INSULIN CARTRIDGE WAS LOW AND E1 WHEN THE INSULIN CARTRIDGE WAS EMPTY. THE PATIENT'S BLOOD GLUCOSE ELEVATED TO 600 MG/DL AND SHE HAD HYPERGLYCEMIC SYMPTOMS OF THIRST, FREQUENT URINATION, AND NAUSEA. SHE BOLUSED THROUGH HER INFUSION DEVICE TO LOWER HER BLOOD GLUCOSE. HER NORMAL BLOOD GLUCOSE RANGE IS 100-200 MG/DL. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED ON A SEPARATE COMPLAINT.

    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 INSULIN| INSULIN INFUSION SET