BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 6046950 · Received October 21, 2016

    Report

    Report Number
    2032227-2016-33564
    Event Type
    Malfunction
    Date Received
    October 21, 2016
    Date of Event
    October 1, 2016
    Report Date
    October 1, 2016
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SYSTEM SENSOR DURING AN INFUSION SET CHANGE. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 314 MG/DL AT THE TIME OF INCIDENT. CUSTOMER INDICATED THAT THEY WILL CALL BACK AFTER THEY FIND THEIR OTHER PUMP. CUSTOMER WAS ADVISED TO CONTACT THEIR DOCTOR REGARDING THEIR HIGH BLOOD GLUCOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698644 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR