BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-TRONPLUS

    MDR report key: 1021839 · Received March 28, 2008

    Report

    Report Number
    2183996-2008-00414
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    March 17, 2008
    Report Date
    March 17, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K022831
    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 PT REPORTED THAT THE ICONS ON THE DISPLAY OF HIS INFUSION DEVICE ARE ERRONEOUS ARE NOT CORRECTLY DISPLAYED ON THE SCREEN. HE STATED THAT THE SCREEN IS NOT CRACKED. TO TROUBLESHOOT THE PT WAS INSTRUCTED TO INSERT A NEW POWER PACK INTO THE INFUSION DEVICE. HE STATED THAT NO ICONS WERE VISIBLE ON THE DISPLAY. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REQUESTED TO BE RETURNED FOR EVAL.

    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 INSULIN INFUSION SET| INSULIN