BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 5429579 · Received February 10, 2016

    Report

    Report Number
    3004209178-2016-85657
    Event Type
    Malfunction
    Date Received
    February 10, 2016
    Date of Event
    December 8, 2015
    Report Date
    January 22, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FINDINGS: PUMP PASSED ALL CURRENT TEST HOWEVER A COMPROMISED FORCE SENSOR ALARM DURING THE BASIC OCCLUSION TEST DUE TO LOOSE/PROTRUDED DRIVE SUPPORT DISK. UNABLE TO PERFORM OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY TEST DUE TO A COMPROMISED FORCE SENSOR ALARM. PUMP RECEIVED WITH CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHED LCD WINDOW, CRACKED BATTERY TUBE THREADS AND MISSING END CAP STICKER. 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 INDICATING THAT THE INSULIN PUMP DOESN'T RECEIVED THE CORRECT VALUE. CUSTOMER'S BLOOD GLUCOSE AT TIME OF INCIDENT WAS 9.2MMOL/L. WE CHECKED THE BLOOD GLUCOSE READER SERIAL NUMBER WHICH WAS CORRECT IN PUMP. CUSTOMER WAS FEELING INSECURE ABOUT THE PUMP AND WAS ADVISED THAT WE ARE REPLACING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85397 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-554WWL

    Patients

    Seq Age Sex Outcome Treatment
    1