BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3974644 · Received August 3, 2014

    Report

    Report Number
    3004209178-2014-89267
    Event Type
    Malfunction
    Date Received
    August 3, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. 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 WAS REPORTED THAT THE SCREEN ON THE INSULIN PUMP GOT "BLACK FILM" WHILE OUTSIDE IN THE HOT WEATHER. ADVISED THE CUSTOMER THAT THIS CAN HAPPEN DUE TO HEAT. THE BLOOD GLUCOSE READING WAS 302.4 MG/DL. ADVISED CUSTOMER TO MONITOR AND TO CALL BACK IF THE ISSUE RECURS IN A REGULAR ENVIRONMENT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452400 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-554CMH

    Patients

    Seq Age Sex Outcome Treatment
    1