BEUDAMED
    FDA Adverse Event Injury Summary report: N

    H-TRONPLUS

    MDR report key: 1030015 · Received April 14, 2008

    Report

    Report Number
    2183996-2008-00521
    Event Type
    Injury
    Date Received
    April 14, 2008
    Date of Event
    March 22, 2008
    Report Date
    April 10, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    APPROX 10 DAYS PRIOR TO 2008, THE PT WAS HOSPITALIZED FOR SEVERE HYPOGLYCEMIC COMA. THE CAUSE FOR THE EVENT IS NOT YET KNOWN. NO FURTHER INFO IS AVAILABLE. PRODUCT WAS REQUESTED TO BE RETURNED FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R INSULIN| INSULIN INFUSION SET