BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3133593 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-94108
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 23, 2013
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 CUSTOMER'S BLOOD GLUCOSE HAD INCREASED UP 400MG/DL FOR SOME DAYS. THE HIGH PRESSURE, DISPLACEMENT, AND SELF TEST WERE PERFORMED AND THEY PASSED. IT WAS STATED THAT TWO MONTHS AGO THE DRIVE SUPPORT CAP WAS LOOSE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237185 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MMT-722WWS

    Patients

    Seq Age Sex Outcome Treatment
    1