BEUDAMED
    FDA Adverse Event Injury Summary report: N

    H-TRONPLUS

    MDR report key: 563950 · Received January 3, 2005

    Report

    Report Number
    2183996-2004-00995
    Event Type
    Injury
    Date Received
    January 3, 2005
    Date of Event
    November 20, 2002
    Report Date
    November 20, 2002
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    LZG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS HOSPITALIZED WITH HIGH BLOOD GLOUSE (> 1000 MG/DL), FOR AN UNSPECIFIED PERIOD, DURING 09/2002. PT DID NOT INDICATE WHAT TREATMENT WAS RECEIVED WHILE HOSPITALIZED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R INSULIN, INSULIN INFUSION SET, DATE(S) OF| 2002.| TREATMENT: UNSPECIFIED PERIOD DURING SEPTEMBER