BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3933352 · Received July 14, 2014

    Report

    Report Number
    2032227-2014-03670
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    MEDTRONIC MINIMED
    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 PASSED THE REWIND, BASIC OCCLUSION, PRIME AND DISPLACEMENT TESTS. THE INSULIN PUMP WAS RECEIVED STUCK IN A MOTOR ERROR ALARM DURING BOLUS DELIVERY LOOP. NO MOTOR ENCODER POSITION ERROR ALARM COULD BE VERIFIED DUE TO AN ERASED HISTORY FILE. NO MOTION SENSOR TEST FAILURE ALARM COULD BE VERIFIED DUE TO THE MOTOR ERROR ALARM. 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 WAS RECEIVED WITH A CRACKED RESERVOIR TUBE LIP AND MINOR SCRATCHES ON THE DISPLAY WINDOW.

    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. THE DEVICE WILL BE RETURN 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 THAT THE CUSTOMER'S INSULIN PUMP WAS MALFUNCTIONING. IT WAS ALARMING MOTOR ERROR DURING BOLUS/BASAL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409162 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-554LWWB

    Patients

    Seq Age Sex Outcome Treatment
    1