BEUDAMED
    FDA Adverse Event Injury Summary report: N

    H-TRONPLUS

    MDR report key: 1012657 · Received March 11, 2008

    Report

    Report Number
    2183996-2008-00315
    Event Type
    Injury
    Date Received
    March 11, 2008
    Date of Event
    February 26, 2008
    Report Date
    February 26, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K023471
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTED HE RECEIVES AN 04 (OCCLUSION) ERROR MESSAGE ON HIS INSULIN INFUSION DEVICE EVERY TIME HE TRIES TO BOLUS. HE STATED HE HAS CHANGED HIS INFUSION HEADSET, BUT HE STILL GETS THE OCCLUSION MESSAGE. DURING TROUBLESHOOTING, THE PT STATED THE PISTON ROD AND ADAPTER ON HIS INFUSION DEVICE ARE BOTH APPROX 1 Y/O. THE PT WAS ADVISED THE PISTON ROD MUST BE CHANGED EVERY YEAR AND THE ADAPTER EVERY 6 MONTHS. THE PT SAID THE EXPIRATION DATE ON THE CARTRIDGES HE IS CURRENTLY USING IS 06/2007. THE PT WAS ADVISED NOT TO USE EXPIRED PRODUCTS. THE PT WAS INSTRUCTED TO DISCONNECT FROM HIS INFUSION HEADSET AND TRY TO BOLUS WITHOUT HIS INFUSION SET TUBING ATTACHED. THE BOLUS WENT THROUGH WITHOUT ERROR. THE PT WAS THEN INSTRUCTED TO RE-INSTALL THE CARTRIDGE, ADAPTER, AND PISTON ROD AND PERFORM A BOLUS. AN OCCLUSION MESSAGE WAS RECEIVED. THE PT STATED HE HAS AN EVALUATED BLOOD GLUCOSE READING OF 440 MG/DL WITH HIS NORMAL READING BEING 100 MG/DL. HE SAID HE IS NOT EXPERIENCING ANY SYMPTOMS AND WILL TREAT HIS READING BY BOLUSING INSULIN BY INJECTION. THE PT WAS SENT NEW CARTRIDGES, 2 NEW PISTON RODS, AN ADAPTER AND BATTERIES. ON FOLLOW UP, THE PT STATED HE HAD TRIED THE NEW SUPPLIES, BUT THE DEVICE WAS STILL GIVING THE OCCLUSION MESSAGE. THE PT DID NOT REQUIRE 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 INSULIN INFUSION PUMP LZG DISETRONIC MEDICAL SYSTEMS H-TRONPLUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INSULIN| INSULIN INFUSION SET