BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3090735 · Received May 2, 2013

    Report

    Report Number
    3004209178-2013-93068
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    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. THE DEVICE WILL BE RETURNED 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 A 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 PASSED DISPLACEMENT TEST, REWIND AND BASIC OCCLUSION TEST. THE INSULIN PUMP RECEIVED WITH MOTOR ERROR ALARM LOOP DURING BOLUS DELIVERY AND A CONFIRMED ALARM IN ALARM HISTORY SCREEN. MOTOR WAS TESTED OUTSIDE THE DEVICE AND PASSED. MOTOR MAY HAVE HAD AN INTERMITTENT FAILURE NOT DETECTED DURING OUR TESTING. UNABLE TO CONFIRM EXCESSIVE NO DELIVERY ALARM TEST DUE TO MOTOR ERROR ALARM. MISSING END CAP STICKER NOTED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT INSULIN PUMP ALARMED MOTOR ERROR. CUSTOMER'S BLOOD GLUCOSE IS 15.6 MMOL/L. DRIVE SUPPORT DISK IS NORMAL. CUSTOMER STATES THAT THEY ARE ABLE TO REWIND THE INSULIN PUMP. PERFORMED DISPLACEMENT TEST, TEST FAILED. ADVISED CUSTOMER THAT INSULIN PUMP REQUIRES REPLACEMENT AND TO DISCONTINUE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192387 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