BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-TRONPLUS

    MDR report key: 1184612 · Received September 29, 2008

    Report

    Report Number
    2183996-2008-01471
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 4, 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
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED THE DISPLAY OF HIS INFUSION DEVICE WAS PARTIAL. THE BATTERY IN USE WAS EXPIRED (2006-12). HE WAS ADVISED TO INSERT A NEW BATTERY BUT HE DID NOT HAVE ANY THAT WERE NOT EXPIRED. HE WAS SENT REPLACEMENT BATTERIES. THE NEW BATTERIES DID NOT RESTORE THE DISPLAY. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL 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 40 YR INSULIN INFUSION SET| INSULIN