BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-TRON PLUS

    MDR report key: 1082005 · Received July 23, 2008

    Report

    Report Number
    2183996-2008-01087
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    July 4, 2008
    Report Date
    July 4, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K043000
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED HE WAS MISSING PART OF THE DISPLAY ON HIS INSULIN INFUSION DEVICE. HE STATED THAT PART OF THE TIME AT THE TOP OF THE DISPLAY SCREEN IS MISSING, AND ALL OF THE NUMBERS TO THE RIGHT OF THE DECIMAL POINT IN THE UNITS PER HOUR ARE MISSING. HE STATED HE CHANGED THE BATTERY PACK 2 DAYS AGO. DURING THE CALL, THE PATIENT CHANGED TO A NEW BATTERY BUT THIS DID NOT RESOLVE THE ISSUE. THE PATIENT WAS ASSISTED WITH GOING THROUGH THE STANDARD BOLUS PROCESS TO SUCCESSFULLY DELIVER A BOLUS FOR THE FOOD THE PATIENT HAD JUST EATEN. THE PATIENT DID NOT REPORT BLOOD GLUCOSE CONCERNS RELATED TO THIS ISSUE. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN INFUSION SET| INSULIN