BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-TRONPLUS

    MDR report key: 1162794 · Received September 8, 2008

    Report

    Report Number
    2183996-2008-01341
    Event Type
    Malfunction
    Date Received
    September 8, 2008
    Date of Event
    June 22, 2008
    Report Date
    August 22, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K043000
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED THAT A COUPLE OF MONTHS AGO, HE DROPPED HIS INSULIN INFUSION DEVICE AND CRACKED THE DEVICE CASE. HE STATED THE DEVICE WAS WORKING PROPERLY, UNTIL A COUPLE OF NIGHTS AGO, WHEN IT WAS DROPPED INTO WATER. THE PT IMMEDIATELY REMOVED THE DEVICE FROM THE WATER AND DRIED IT. THE PT STATED HE WAS WORKING IN VERY WET CONDITIONS YESTERDAY. HE SAID THE DEVICE SCREEN IS NOW VERY DIFFICULT TO READ AND APPEARS TO HAVE MOISTURE UNDER IT. THE PT WAS ADVISED TO STOP USING THE DEVICE. THE PT DID NOT REPORT BLOOD GLUCOSE CONCERNS RELATED TO THIS ISSUE. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THIS ISSUE. PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR INSULIN INFUSION SET| INSULIN