BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3850005 · Received June 4, 2014

    Report

    Report Number
    3004209178-2014-85427
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 21, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. 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

    ALL OPERATING CURRENTS WERE WITHIN SPECIFICATION. NO UNEXPECTED LOW BATTERY OR OFF NO POWER ALARMS NOTED. THE PUMP PASSED THE OFF NO POWER, SELF TEST, UNEXPECTED RESTART, DISPLACEMENT, AND REWIND TESTS. THE PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM DURING THE BASIC OCCLUSION TESTS AND UNABLE TO PRIME DURING THE PRIME TEST DUE TO A LOOSE/PROTRUDED DRIVE SUPPORT DISK. UNABLE TO COMPLETE THE FUNCTIONAL TESTS, INCLUDING THE OCCLUSION AND EXCESSIVE NO DELIVERY ALARM TESTS DUE TO THE COMPROMISED FORCE SENSOR SYSTEM ALARM. THE PUMP HAD INTERMITTENT BUTTON RESPONSE DURING TESTING DUE TO CORRODED KEYPAD TRACES. THE PUMP WAS RECEIVED WITH A CRACKED CASE ON THE DISPLAY WINDOW CORNERS, MINOR SCRATCHES ON THE LCD WINDOW, A CRACKED RESERVOIR TUBE, A CRACKED RESERVOIR TUBE LIP, A BROKEN BELT CLIP SLOT, CRACKED BATTERY TUBE THREADS, AND A MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP ALARMED AFTER CHANGING THE INFUSION SET. THE BLOOD GLUCOSE READING WAS 2.7MMOL/L. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP WAS FLUSH. 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
    326022 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722CAS

    Patients

    Seq Age Sex Outcome Treatment
    1