BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    H-TRONPLUS

    MDR report key: 1100138 · Received August 5, 2008

    Report

    Report Number
    2183996-2008-01150
    Event Type
    Malfunction
    Date Received
    August 5, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 10, 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

    IN 2008, THE PATIENT REPORTED HE RECEIVED AN 04 (OCCLUSION) MESSAGE ON HIS INSULIN INFUSION DEVICE WHILE TRYING TO BOLUS. HE STATED HE CHANGED THE INSULIN CARTRIDGE AND HIS INFUSION HEADSET AND TUBING. DURING TROUBLESHOOTING, THE PATIENT WAS INSTRUCTED TO PUSH EITHER THE H OR M BUTTON ON THE DEVICE AND HOLD IT UNTIL THE ARROW POINTED TO BOLUS. THE PATIENT TRIED BOTH BUTTONS BUT THE ARROW NEVER POINTED TO BOLUS. HE STATED HE RECEIVED HIS BASAL RATE AND DID NOT RECEIVE ANOTHER OCCLUSION ERROR BUT HE WAS NOT ABLE TO PROGRAM A BOLUS. THE PATIENT STATED HE IS USING "BRAND NEW BATTERIES" HE REMOVED FROM THE BOX YESTERDAY. HE DID NOT PROVIDE THE EXPIRATION DATE. THE PATIENT DID NOT REPORT ANY BLOOD GLUCOSE CONCERNS RELATED TO THIS ISSUE. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM THE HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THIS ISSUE. 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 NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR INSULIN INFUSION SET| INSULIN