BEUDAMED
    FDA Adverse Event Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3990159 · Received August 7, 2014

    Report

    Report Number
    2032227-2014-05874
    Date Received
    August 7, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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

    IT IS REPORTED THAT THE PATIENT EXPERIENCED A BLANK SCREEN ON THEIR INSULIN PUMP. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. TROUBLE SHOOTING WAS PERFORMED AND ISSUE WAS RESOLVED. PUMP NOT RETURNED. NO FURTHER INFORMATION AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463409 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR