BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3973984 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-88973
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. 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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH STUCK IN MOTOR ERROR ALARM LOOP DURING BOLUS AND BASAL DELIVERY, THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED. THE MOTOR MAY HAVE HAD AN INTERMITTENT FAILURE THAT WAS NOT DETECTED DURING OUR TESTING. THE INSULIN PUMP PASSED DISPLACEMENT, REWIND, BASIC OCCLUSION AND PRIME/A33TESTS. THE INSULIN PUMP HAS CRACKED RESERVOIR TUBE LIP AND MISSING END CAP TICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CUSTOMER'S INSULIN PUMP ALARMED MOTOR ERROR. THERE WERE NO SIGNIFICANT EVENTS LEADING TO THE ALARM. CUSTOMER DOES NOT USE THE SENSOR FEATURE. THE ALARM OCCURRED DURING REWIND. CUSTOMER'S BLOOD GLUCOSE WAS NOT PROVIDED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450893 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-554WWS

    Patients

    Seq Age Sex Outcome Treatment
    1