BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-TRON PLUS

    MDR report key: 3253658 · Received July 30, 2013

    Report

    Report Number
    2183996-2013-01415
    Event Type
    Malfunction
    Date Received
    July 30, 2013
    Date of Event
    July 12, 2013
    Report Date
    August 27, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT STATED THAT THE PUMP HAD INTENTIONAL WATER CONTACT. THE PUMP IS NOT WATERPROOF FOR SWIMMING OR OTHER CONTACTS WITH WATER. THEREFORE, MOISTURE ENTERED THE INSULIN PUMP AND CAUSED DAMAGES TO THE PUMP BUTTONS AND ELECTRONICS. THE BUTTONS AND THE PUMP ELECTRONIC ARE CORRODED DUE TO LIQUID HAS ENTERED INTO THE PUMP. THE PROBLEM IS RELATED TO MISHANDLING OF THE PRODUCT BY THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT A WEEK AGO THE PATIENT'S INFUSION DEVICE FELL INTO THE WATER. THAT EVENING THE PATIENT NOTICED WATER UNDER THE DEVICE'S DISPLAY. THE FOLLOWING DAY THE PATIENT'S BLOOD GLUCOSE LEVEL WAS ELEVATED TO 500 MG/DL AND HE FOUND THAT THE BUTTONS ON THE DEVICE WOULD NO LONGER FUNCTION. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354727 D-TRON PLUS INSULIN INFUSION PUMP LZG ROCHE HEALTH SOLUTIONS INC 00700006842 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 052 YR