BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    H-TRONPLUS PISTON ROD

    MDR report key: 1033521 · Received April 23, 2008

    Report

    Report Number
    2183996-2008-00574
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    April 14, 2008
    Report Date
    April 14, 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
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTED RECEIVING REPEATED OCCLUSION ERRORS ON HIS INSULIN INFUSION DEVICE WHEN HIS DEVICE IS IN THE RUN MODE. HE STATED HE REPLACED THE PISTON ROD 4 MONTHS AGO AND THE ADAPTER ABOUT ONE YEAR AGO. TO TROUBLESHOOT, THE PT WAS INSTRUCTED TO DISCONNECT FROM HIS INFUSION HEADSET AND PLACE HIS DEVICE IN RUN. AN OCCLUSION ERROR WAS RECEIVED. THE PT WAS THEN INSTRUCTED TO REMOVE THE INFUSION SET TUBING WHICH WAS OVER 6 DAYS OLD. ANOTHER OCCLUSION ERROR WAS RECEIVED. THE PT'S INSULIN CARTRIDGE WAS LOW AND WHEN HE WENT TO REPLACE IT, HE NOTICED THE PISTON ROD WAS STUCK IN THE BOTTOM OF THE INFUSION DEVICE AND ITS BLUE COG WHEEL WOULD NOT SPIN FREELY. THE PT THEN INSERTED A NEW PISTON ROD WHICH RESOLVED THE ISSUE. THE PT DID NOT REPORT BLOOD GLUCOSE CONCERNS RELATED TO THIS ISSUE. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN INFUSION SET| INSULIN INFUSION PUMP| INSULIN