BEUDAMED
    FDA Adverse Event Injury Summary report: N

    D-TRONPLUS

    MDR report key: 543609 · Received September 13, 2004

    Report

    Report Number
    2183996-2004-00655
    Event Type
    Injury
    Date Received
    September 13, 2004
    Date of Event
    August 31, 2004
    Report Date
    September 1, 2004
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    LZG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT WENT ON A STRENUOUS KAYAKING TRIP IN 2004, THEN THE FOLLOWING DAY THEY FELT A TIGHTENING IN THEIR CHEST. PT WAS TAKEN TO HOSP VIA AMBULANCE. PT'S BLOOD GLUCOSE AT HOSP WAS 26.2 MMOL/L, SO PT BOLUSED INSULIN, BUT BLOOD GLUCOSE DID NOT PERMANENTLY DECREASE. PT WAS THEN TREATED WITH IV INSULIN. NEXT DAY, (WHILE STILL IN THE HOSP), PT EXPERIENCED AN INSULIN REACTION (THEY WERE SWEATING PROFUSELY AND NOT THINKING VERY WELL). PT WAS TREATED BY NURSE WITH FIVE "DEXTERSOL" TABLETS (6.1 CARBS PER TABLET), FOOD, AND DRINK. PT WAS STILL IN HOSP AT TIME OF REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R INSULIN, INSULIN INFUSION SET, DATES OF| TREATMENT: 2004.