BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1261261 · Received December 10, 2008

    Report

    Report Number
    2183996-2008-01849
    Event Type
    Injury
    Date Received
    December 10, 2008
    Date of Event
    November 15, 2008
    Report Date
    November 18, 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
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PATIENT'S DAUGHTER REPORTED THAT THE PATIENT WAS HOSPITALIZED THREE DAYS PRIOIR, DUE TO HYPERGLYCEMIA. SHE STATED THAT HE BEGAN TO FEEL DIZZY AND HE WENT TO HIS DOCTOR'S OFFICE. HIS BLOOD GLUCOSE MEASURED 523 MG/DL AND HE WAS SENT TO THE EMERGENCY ROOM WHERE HE WAS TREATED WITH AN IV DRIP AND INSULIN TO LOWER HIS BLOOD GLUCOSE. HE WAS RELEASED FROM THE HOSPITAL THREE DAYS LATER. HIS PHYSICIAN BELIEVES THE INFUSION DEVICE IS NOT DELIVERING INSULIN PROPERLY. HE SWITCHED TO HIS BACKUP INFUSION DEVICE. THE PATIENT WAS SENT A REPLACEMENT INFUSION DEVICE. UPON FOLLOW UP IN THE SAME MONTH, THE PATIENT REPORTED THAT HIS BLOOD GLUCOSE HAD IMPROVED SINCE RECEIVING THE REPLACEMENT DEVICE. 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 66 YR Hospitalization| O| R INSULIN INFUSION SET| INSULIN| DATE OF TREATMENT: 2008-2008