BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    H-TRONPLUS

    MDR report key: 1012846 · Received March 11, 2008

    Report

    Report Number
    2183996-2008-00304
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 25, 2008
    Report Date
    February 25, 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
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTED HER INSULIN INFUSION DEVICE HAS 2 WEEKS OF LIFE LEFT. SHE THEN STATED THE DEVICE STOPPED FUNCTIONING TODAY WHEN SHE TRIED TO PRIME. A COMPANY REPRESENTATIVE OFFERED TO TROUBLESHOOT THE ISSUE, BUT THE PATIENT DECLINED STATING SHE DID NOT HAVE TIME. REPEATED ATTEMPTS TO FOLLOW UP WITH THE PATIENT WERE UNSUCCESSFUL. THE PATIENT DID NOT REPORT BLOOD GLUCOSE CONCERNS RELATED TO THIS ISSUE. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION SET