BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHECK SPIRIT

    MDR report key: 1050304 · Received May 22, 2008

    Report

    Report Number
    2183996-2008-00757
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    May 13, 2008
    Report Date
    May 14, 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
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT'S ROOMMATE REPORTED THE PT WAS IN THE HOSPITAL DIAGNOSED WITH KETOACIDOSIS. HE STATED THAT THE PT WAS USING HER BACKUP INSULIN INFUSION DEVICE AND SHE, ALONG WITH HER DOCTOR, THINKS THE DEVICE MALFUNCTIONED. THE ROOMMATE STATED HE HAD NO DETAILS AS TO HOW THE DEVICE MALFUNCTIONED. HE STATED THE PT'S SYMPTOMS WERE FREQUENT URINATION AND THROWING UP. HE STATED HER BLOOD GLUCOSE READING WAS 578 MG/DL AND HE GAVE HER AN INJECTION OF INSULIN WHICH DECREASED HER READING TO 270 MG/DL. HE STATED HE TOOK HER TO THE HOSPITAL WHEN HER READINGS BEGAN ONCE MORE TO ELEVATE. HE SAID UPON ADMITTANCE TO THE HOSPITAL SHE WAS DEHYDRATED AND HER BLOOD GLUCOSE READING WAS OVER 500 MG/DL. THE PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R DATE OF TREATMENT| INSULIN| INSULIN INFUSION SET