BEUDAMED
    FDA Adverse Event Injury Summary report: N

    H-TRONPLUS V 100

    MDR report key: 1013660 · Received March 14, 2008

    Report

    Report Number
    2183996-2008-00348
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    March 5, 2002
    Report Date
    March 5, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K973044
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT 4-6 YEARS AGO, WHILE USING HER PREVIOUS INSULIN INFUSION DEVICE, SHE HAD A LOW BLOOD GLUCOSE EVENT. SHE STATED SHE PASSED OUT BUT DOES NOT REMEMBER ANY OTHER SPECIFICS AS IT WAS SO LONG AGO. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WAS AVAILABLE TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 H-TRONPLUS V 100 INSULIN INFUSION PUMP LZG DISETRONIC MEDICAL SYSTEMS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INSULIN| INSULIN INFUSION SET