BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    H-TRONPLUS

    MDR report key: 593957 · Received April 11, 2005

    Report

    Report Number
    2183996-2005-00207
    Event Type
    Malfunction
    Date Received
    April 11, 2005
    Date of Event
    March 7, 2005
    Report Date
    March 10, 2005
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE (250-460 MG/DL), FOR 3 DAYS. THEY INDICATED THAT THEY HAD ATTEMPTED TO LOWER BLOOD GLUCOSE BY DELIVERING SEVERAL LARGE BOLUSES; HOWEVER, THEIR BLOOD GLUCSE DID NOT DECREASE, AS EXPECTED. NO ERROR MESSAGES WERE GENERATED BY THE DEVICE. PT STATED THAT, BEFORE GOING TO SLEEP, THEY SWITCHED TO THEIR BACK-UP DEVICE, AND DELIVERED A 10U BOLUS. THE FOLLOWING MORNING, PT'S BLOOD GLUCOSE MEASURED 85 MG/DL. PT INDICATED THAT THEY BELIEVE THAT THE ORIGINAL DEVICE WAS NOT DELIVERING THE PROPER AMOUNT OF INSULIN, AND WAS AT FAULT FOR ELEVATED BLOOD GLUCOSE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR DATE OF TREATMENT: NA.| INSULIN, INSULIN INFUSION SET: