BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4241469 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-50613
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 13, 2014
    Report Date
    March 7, 2018
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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. 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.

    Additional Manufacturer Narrative · 1

    UNIT WAS RECEIVED WITH NORMAL OPERATING CURRENTS AND PASSED SELF-TEST, UNEXPECTED RESTART ERROR TEST AND DISPLACEMENT TEST. NO UNEXPECTED LOW BATTERY, BATTERY OUT LIMIT AND FAILED BATTERY TEST ALARMS DURING TESTING. UNIT HAD MINOR SCRATCHED LCD WINDOW, CRACKED LCD WINDOW, CRACKED RESERVOIR TUBE LIP, CRACKED CASE AT DISPLAY WINDOW CORNERS, STAINED ADDRESS/SERIAL NUMBER LABEL AND STAINED END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S BATTERY DEPLETES TWICE IN A WEEK. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 128 MG/DL. THE PRODUCT WILL BE RETURNED. NOTHING FURTHER TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722312 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-754LWWL

    Patients

    Seq Age Sex Outcome Treatment
    1