BEUDAMED
    FDA Adverse Event Injury Summary report: N

    H-TRONPLUS V100 INSULIN INFUSION PUMP

    MDR report key: 477768 · Received August 14, 2003

    Report

    Report Number
    2183996-2003-00176
    Event Type
    Injury
    Date Received
    August 14, 2003
    Date of Event
    July 12, 2003
    Report Date
    July 15, 2003
    Manufacturer
    DISETRONIC MEDICAL SYSEMS, INC.
    Product Code
    LZG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS TREATED AT HOSPITAL FOR HYPERGLYCEMIA. PUMP NOT RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 H-TRONPLUS V100 INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG DISETRONIC MEDICAL SYSEMS, INC. H-TRONPLUS V-100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization INSULIN,| DATES OF TREATMENT-NA| INSULIN INFUSION SET,