BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3854494 · Received June 6, 2014

    Report

    Report Number
    3004209178-2014-85342
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED DURING THE BASIC OCCLUSION TEST DUE TO A LOOSE AND PROTRUDED DRIVE SUPPORT DISK. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE AT A DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED DISPLAY WINDOW AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN SQUIRTED OUT DURING THE MANUAL PRIME PROCESS AND THE INSULIN PUMP ALARMED. THE BLOOD GLUCOSE READING WAS 99 MG/DL. THE CUSTOMER WAS CONCERNED THAT THE INSULIN PUMP WAS DELIVERING TOO MUCH INSULIN DURING HIS FIXED PRIME. TROUBLESHOOTING WAS PERFORMED, AND NO DAMAGE TO THE DRIVE SUPPORT CAP NOTED. THE CUSTOMER CHANGED THE RESERVOIR AND HAD THE SAME RESULTS. ADVISED THE CALLER TO DISCONTINUE THE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332170 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR