BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-TRONPLUS

    MDR report key: 1212731 · Received October 22, 2008

    Report

    Report Number
    2183996-2008-01609
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 8, 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
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B) (6) 2008, THE PT REPORTED THAT HE RECEIVED AN E2 (BATTERY DEPLETED) ERROR AND THE DISPLAY OF HIS INFUSION DEVICE IS ONLY PARTIALLY VISIBLE. HE WAS SENT REPLACEMENT BATTERIES TO THE HOTEL WHERE HE WAS STAYING. UPON F/U ON (B) (6) 2008, THE PT STATED THAT HE WAS ABLE TO RESOLVE THE E2 ERROR BUT THE DISPLAY OF THE INFUSION DEVICE REMAINED PARTIALLY VISIBLE. 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 51 YR INSULIN| INSULIN INFUSION SET