BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 6108043 · Received November 16, 2016

    Report

    Report Number
    2032227-2016-42667
    Event Type
    Malfunction
    Date Received
    November 16, 2016
    Date of Event
    October 24, 2016
    Report Date
    March 23, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. (B)(4).

    Additional Manufacturer Narrative · 1

    AFTER FURTHER REVIEW OF THE COMPLAINT, IT WAS DETERMINED SECTION E1 WAS FILLED OUT INCORRECTLY IN THE INITIAL COMPLAINT. A CORRECTION HAS BEEN MADE ON THIS REPORT.

    Additional Manufacturer Narrative · 1

    THE PUMP HAD MISSING SEGMENTS/HORIZONTAL LINE DUE TO A CRACKED LCD ZEBRA CONNECTOR. THE PUMP PASSED THE IDLE CURRENT, RUN CURRENT, OFF NO POWER, UNEXPECTED RESTART, BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY, DISPLACEMENT AND REWIND TESTS. THE PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW AND A CRACKED RESERVOIR TUBE LIP. NO DAMAGE ON THE ADDRESS/SERIAL NUMBER LABEL WAS NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP IS DAMAGED AND THE DISPLAY SCREEN APPEARS TO HAVE LINES GOING THROUGH IT. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. TROUBLESHOOTING FOUND THAT THE LINES DO NOT DISAPPEAR WITH ANY BUTTON PRESS. NO FURTHER DETAILS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758267 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-515WWP

    Patients

    Seq Age Sex Outcome Treatment
    1