BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK D-TRON PLUS

    MDR report key: 1000989 · Received February 19, 2008

    Report

    Report Number
    2183996-2008-00166
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    February 1, 2008
    Report Date
    February 6, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    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 REPORTED THAT SHE WENT FOR A WALK WITH HER MOTHER AND THEN HAS NO MEMORY OF WHAT HAPPENED NEXT. THE MOTHER INFORMED THE PT THAT SHE WAS "VACILLATED" AND CONFUSED AND THEN BECAME UNCONSCIOUS. THE PT'S MOTHER CALLED THE EMERGENCY PHYSICIAN AND THE PT'S BLOOD GLUCOSE MEASURED 32 MG/DL. THE PT WAS GIVEN A GLUCOSE IV AND WAS DISCONNECTED FROM THE INFUSION DEVICE. THE PT WAS TRANSPORTED TO HOSP BY AMBULANCE AND WAS ADMITTED TO THE INTENSIVE CARE UNIT OVER NIGHT. HER BLOOD GLUCOSE ELEVATED TO 400 MG/DL DUE TO THE GLUCOSE IV. THE PT RECONNECTED TO THE INFUSION DEVICE TWO DAYS LATER, AND STATED THAT THE BASAL DELIVERY WAS TOO HIGH. HER NORMAL BASAL RATE IS 18 UNITS OF INSULIN PER DAY AND THE INFUSION DEVICE WAS PROGRAMMED TO DELIVER 25 UNITS PER DAY. THE PT'S NORMAL BLOOD GLUCOSE LEVEL IS 100 MG/DL. NO FURTHER INFO IS AVAILABLE. PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK D-TRON PLUS INSULIN INFUSION PUMP LZG DISETRONIC MEDICAL SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization| R INSULIN| INSULIN INFUSION SET