BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4233663 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48928
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 9, 2014
    Report Date
    June 24, 2016
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH BLANK DISPLAY DUE TO MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY; MOISTURE DAMAGE WAS ALSO FOUND ON THE MOTOR ASSEMBLY. UNABLE TO PERFORM FUNCTIONAL CHECK INCLUDING REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, THE EXCESSIVE NO DELIVERY, DISPLACEMENT, SELF-TEST, A21 TEST AND ALL OPERATING CURRENT TEST DUE TO BLANK DISPLAY. NO UNEXPECTED AUDIO BEEP NOTED DURING OUR TESTING. THE INSULIN PUMP HAD MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT THE DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP AND SCRATCHED RESERVOIR TUBE WINDOW.

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A BEEP ANOMALY AND A BLANK DISPLAY. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT REPORTED. THE CUSTOMER WAS ADVISED TO REVERT TO BACK UP PLAN. THE PRODUCT WILL BE RETURNED. NOTHING FURTHER TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715507 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-754LWWS

    Patients

    Seq Age Sex Outcome Treatment
    1