BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4820189 · Received June 4, 2015

    Report

    Report Number
    3004209178-2015-62760
    Event Type
    Malfunction
    Date Received
    June 4, 2015
    Date of Event
    May 13, 2015
    Report Date
    May 18, 2015
    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
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPOSED THE INSULIN PUMP TO MOISTURE. THE CUSTOMER LEFT THE INSULIN PUMP IN THE WASTER FOR TWO MINUTES. IT WAS ALSO FOUND THE CUSTOMER HAD A NO RESERVOIR ALARM WITH THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. THE CUSTOMER STATED THERE WAS FLUID PRESENT UNDER THE LCD DISPLAY. CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED. CUSTOMER AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362925 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR