BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-TRONPLUS

    MDR report key: 1250026 · Received November 14, 2008

    Report

    Report Number
    2183996-2008-01736
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    October 31, 2008
    Report Date
    October 31, 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
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED SHE RECEIVED A TRAVEL INSULIN INFUSION DEVICE AS HER PRIMARY DEVICE REACHED ITS END OF LIFE AND SHE IS IN PERU. SHE STATED SHE OPENED THE BOX WITH THE TRAVEL DEVICE AND NOTICED THE CHARACTERS ON ITS DISPLAY ARE INCOMPLETE. SHE SAID THERE ARE NO BLACK SPOTS BUT THAT SEGMENTS ARE MISSING ON THE DISPLAY. THE PT WAS INSTRUCTED TO INSERT A NEW POWER PACK BUT THIS DID NOT RESOLVE THE ISSUE. NO BLOOD GLUCOSE CONCERNS RELATED TO THIS ISSUE WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE 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 55 YR INSULIN| INSULIN INFUSION SET