BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1031266 · Received April 18, 2008

    Report

    Report Number
    2183996-2008-00557
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    February 18, 2008
    Report Date
    April 15, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT WAS FOUND UNCONSCIOUS AND A FRIEND CONTACTED THE EMERGENCY DR. HIS BLOOD GLUCOSE WAS ELEVATED TO 900 MG/DL. HIS NORMAL BLOOD GLUCOSE LEVEL IS 140 MG/DL. HE WAS RELEASED FROM THE HOSPITAL 2 DAYS LATER, AND HE RECEIVED DIABETIC TRAINING. NO FURTHER INFO IS AVAILABLE. PRODUCT WAS REPLACED AND 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 44 YR Hospitalization| O| R INSULIN| INSULIN INFUSION SET