BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    H-TRONPLUS

    MDR report key: 1030187 · Received April 14, 2008

    Report

    Report Number
    2183996-2008-00518
    Event Type
    Malfunction
    Date Received
    April 14, 2008
    Date of Event
    January 2, 2008
    Report Date
    April 2, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K023471
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WIL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON 04/02/2008 A COMPANY REPRESENTATIVE REPORTED THAT THE PATIENT IS NOT RECEIVING THE CARTRIDGE LOW WARNING (E10) ON HER INFUSION DEVICE. THE PATIENT STATED THAT THIS BEGAN 2-3 MONTHS AGO. SHE STATED THAT SHE FILLS HER INSULIN CARTRIDGES TO 315 UNITS, AND RESETS THE INFUSION DEVICE TO A FULL CARTRIDGE WITH EACH CARTRIDGE CHANGE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION, HOWEVER, THE PATIENT REFUSED TO RETURN IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 H-TRONPLUS INSULIN INFUSION PUMP LZG DISETRONIC MEDICAL SYSTEMS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN INFUSION SET| INSULIN