BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3850007 · Received June 4, 2014

    Report

    Report Number
    3004209178-2014-85428
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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 INSULIN PUMP ALARMED BUTTON ERROR. THE CUSTOMER ALREADY ATTEMPTED TO RESTART THE INSULIN PUMP BY REMOVING THE BATTERY FOR A FEW HOURS WITHOUT RESULT. IT WAS STATED THAT THE PATIENT WORE THE DEVICE IN THE BRA AND POSSIBLE THE BUTTONS WERE PUSHED LONGER THEN THREE MINUTES. ADVISED THE CALLER TO USE THE BACK UP PLAN, BUT THE CUSTOMER DID NOT KNOW HOW TO USE IT. THEN THE DAUGHTER DECIDED TO LEAVE HER IN THE HOSPITAL FOR TWO DAYS. DURING THE CALL THE CUSTOMER FELT FINE AND HER GLUCOSE LEVEL WAS NOT AS HIGH. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326661 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722WWH

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization