BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4200788 · Received October 24, 2014

    Report

    Report Number
    2032227-2014-42783
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP POWERED UP PROPERLY AND THE SCREEN DISPLAYED NORMALLY, NO BLANK DISPLAY WAS NOTED. THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM DURING THE BASIC OCCLUSION TEST DUE TO PROTRUDED/LOOSE DRIVE SUPPORT DISK. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE LCD WINDOW, CRACKED BATTERY TUBE THREADS, BROKEN BELT CLIP SLOT, AND CRACKED RESERVOIR TUBE LIP.

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4). 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 THE INSULIN PUMP ALARMED DURING MANUAL PRIME AND INSULIN WAS SQUIRTING OUT. CUSTOMER WAS DISCONNECTED DURING PRIME. THE PISTON KEPT MOVING FORWARD AFTER RESERVOIR CONTACT. NO NUMBERS OR BEEPS ON THE DEVICE. CUSTOMER WAS UNABLE TO EXIT PRIME SEQUENCE. CUSTOMER ATTEMPTED USING ANOTHER SET. THE DEVICE WAS NOT DROPPED, BUMPED, OR EXPOSED TO WATER. THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. CUSTOMER'S BLOOD GLUCOSE WAS NOT PROVIDED. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679725 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754WWP

    Patients

    Seq Age Sex Outcome Treatment
    1