BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 6011190 · Received October 7, 2016

    Report

    Report Number
    2032227-2016-28375
    Event Type
    Malfunction
    Date Received
    October 7, 2016
    Date of Event
    August 15, 2016
    Report Date
    October 28, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RECEIVED WITH OPERATING CURRENTS WITHIN SPECIFICATION. THE PUMP PASSED THE SELF TEST, UNEXPECTED RESTART, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY AND DISPLACEMENT TESTS. THE PUMP WAS MONITORED AND NO SETTING OFF OR UNEXPECTED ALARMS WERE NOTED. THE PUMP WAS RECEIVED WITH A BROKEN RESERVOIR TUBE LIP, A MISSING O-RING, A CRACKED CASE AT THE RESERVOIR TUBE WINDOW CORNERS, A CRACKED RESERVOIR TUBE WINDOW, A CRACKED CASE AT THE DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS AND MINOR SCRATCHES ON THE LCD 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. 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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP IS CRACKED AND CONSTANTLY ALARMS. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. TROUBLESHOOTING FOUND THAT THE RESERVOIR DOES NOT SCREW IN PROPERLY AND MAY HAVE BEEN SCREWED IN TO TIGHTLY. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN PER THEIR DOCTOR'S INSTRUCTION. THE CUSTOMER WAS ALSO ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661786 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-554CAL

    Patients

    Seq Age Sex Outcome Treatment
    1