BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4243966 · Received November 11, 2014

    Report

    Report Number
    2032227-2014-50813
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    May 27, 2014
    Report Date
    October 16, 2014
    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

    (B)(4). INSULIN PUMP PASSED DISPLACEMENT TEST, BASIC OCCLUSION TEST, PRIME TEST, OPERATING CURRENTS, SELF TEST AND OFF NO POWER TEST. HOWEVER, DEVICE WAS RECEIVED STUCK IN MOTOR ERROR ALARM LOOP DURING BOLUS 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. NO UNEXPECTED LOW BATTERY ALARM NOTED. UNABLE TO TEST EXCESSIVE NO DELIVERY TEST DUE TO MOTOR ERROR ALARM. DEVICE RECEIVED WITH CRACKED BATTERY TUBE THREADS AND CRACKED RESERVOIR TUBE LIP. 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 INSULIN PUMP ALARMED MOTOR ERROR DURING PRIME. THE DEVICE WAS NOT EXPOSED TO A MAGNETIC FIELD. CUSTOMER IS NOT ABLE TO COMPLETE THE REWIND SEQUENCE. CUSTOMER WAS ASSISTED ON PERFORMING THE PRIME PROCESS; INSULIN EXITED TUBING BUT INSULIN PUMP ALARMED MOTOR ERROR AGAIN. BLOOD GLUCOSE VALUE IS 6.8 MMOL/L. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725623 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754WWP

    Patients

    Seq Age Sex Outcome Treatment
    1