BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4233741 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-49164
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    September 18, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP RETURNED MULTIPLE NO DELIVERY ALARMS. CUSTOMER REPORTED THAT THE ALARMS OCCUR IMMEDIATELY AFTER INSERTION OR AFTER A DAY OF WEAR. CUSTOMER REPORTED THAT THE NO DELIVERY ALARMS ARE GENERALLY RESOLVED BY A SET CHANGE. BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714600 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR