BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 5791403 · Received July 13, 2016

    Report

    Report Number
    3004209178-2016-57761
    Event Type
    Malfunction
    Date Received
    July 13, 2016
    Date of Event
    July 1, 2016
    Report Date
    September 6, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED STUCK IN THE 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. UNABLE TO CONFIRM E70 ERROR ALARM IN ALARM HISTORY DUE TO HISTORY FILE WAS OVERWRITTEN. HOWEVER, THE INSULIN PUMP PASSED DISPLACEMENT TEST, REWIND, BASIC OCCLUSION AND PRIME TESTS. THE INSULIN PUMP HAD MINOR SCRATCHED LCD WINDOW, CRACKED BATTERY TUBE THREADS, CRACKED BELT CLIP SLOT AT THE BATTERY TUBE THREADS AREA, CRACKED RESERVOIR TUBE LIP AND CRACKED RESERVOIR TUBE WINDOW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED MOTOR ERROR AND MOTOR POSITION ENCODER ERROR. THE CUSTOMER WAS UNABLE TO REWIND THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 9.6 MMOL/L. THE DEVICE WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444228 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