BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-TRONPLUS

    MDR report key: 853466 · Received October 13, 2006

    Report

    Report Number
    2183996-2006-00945
    Event Type
    Malfunction
    Date Received
    October 13, 2006
    Date of Event
    September 24, 2006
    Report Date
    September 24, 2006
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    LZG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    HUSBAND OF A FEMALE, REPORTED INFUSION DEVICE BEEPING AND DISPLAYING "-E--." HE REPLACED POWER PACK, BUT THE "-E--" RECURRED. HE INDICATED PATIENT'S BLOOD GLUCOSE LEVEL WAS ELEVATED TO 311 MG/DL. HER NORMAL RANGE WAS 120-130 MG/DL. PT WAS NOT FEELING ANY SYMPTOMS OF ELEVATED BLOOD GLUCOSE. SHE SWITCHED TO INJECTION THERAPY TO ADDRESS THE ISSUE UNTIL SHE RECEIVED A REPLACEMENT INFUSION DEVICE. THE PATIENT DID NOT REPORT ASSISTANCE BY 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-TRONPLUS INSULIN INFUSION PUMP LZG DISETRONIC MEDICAL SYSTEMS, INC. D-TRONPLUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR INSULIN INFUSION SET| INSULIN INFUSION DEVICE| INSULIN