BEUDAMED
    FDA Adverse Event Injury Summary report: N

    H-TRONPLUS

    MDR report key: 1082226 · Received July 25, 2008

    Report

    Report Number
    2183996-2008-01093
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 15, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K023471
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED THAT AT 6:15AM HER INFUSION DEVICE WAS ALARMING 09 (TECHNICAL INSPECTION DUE). SHE STATED THAT SHE DID NOT KNOW WHEN THE ALARM BEGAN. HER BLOOD GLUCOSE MEASURED "HI" ON HER BLOOD GLUCOSE MONITOR AND SHE FELT NAUSEATED AND THIRSTY. SHE ATTEMPTED TO DRINK WATER BUT VOMITED. SHE INJECTED 85 UNITS OF INSULIN AND HER BLOOD GLUCOSE DECREASED TO 153 MG/DL. HER NORMAL BLOOD GLUCOSE RANGE IS 120-150 MG/DL. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PROD WAS REQUESTED TO BE RETURNED FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INSULIN| INSULIN INFUSION SET