BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1003002 · Received February 21, 2008

    Report

    Report Number
    2183996-2008-00192
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    February 13, 2008
    Report Date
    February 18, 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 Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT ARRIVED AT THE HOSPITAL AT 7 AM WITH A BLOOD GLUCOSE LEVEL OF 1000MG/DL AND HE WAS UNCONSCIOUS. AT 9AM THE PT WAS ADMITTED TO THE INTENSIVE CARE UNIT, AND HIS BLOOD GLUCOSE HAD LOWERED TO 800 MG/DL. AFTER 24 HOURS THE PT WAS ABLE TO COMMUNICATE AND STATED THAT ON THE DAY BEFORE, HE RECEIVED ERRORS (EXACT ERROR UNK) ON HIS INFUSION DEVICE AND HIS BLOOD GLUCOSE WAS ELEVATED TO 300 MG/DL. HE STATED THAT HE WAS NOT ABLE TO CLEAR THE ERROR AND HIS BLOOD GLUCOSE CONTINUED TO ELEVATE. HIS NORMAL BLOOD GLUCOSE RANGE IS 100-200 MG/DL. NO FURTHER INFO IS AVAILABLE. THE INFUSION DEVICE 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 51 YR Hospitalization| O| R INSULIN INFUSION SET| INSULIN