BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4170469 · Received October 14, 2014

    Report

    Report Number
    2032227-2014-37987
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS PROGRAMMED WITH MULTIPLE BOLUSES AND WAS MONITORED. ALL THE BOLUSES WERE DELIVERED AND RECORDED PROPERLY IN THE BOLUS HISTORY SCREEN. NO UNEXPECTED BOLUS DELIVERY ANOMALY WAS NOTED. THE PUMP ALSO HAD A CRACKED CASE AT THE DISPLAY WINDOW CORNER, A CRACKED RESERVOIR TUBE LIP, AND A CRACKED RESERVOIR TUBE WINDOW.

    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. (B)(2).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT ACTIVE INSULIN SHOWS ON STATUS SCREEN ALTHOUGH CUSTOMER HAS NEVER TAKEN A BOLUS WITH THE PUMP. CHECKED BOLUS HISTORY AND LAST BOLUS WAS GIVEN ON THE (B)(6). CUSTOMER HAS STARTED USING PUMP TODAY THE (B)(6) TIME AND DATE CORRECT IN PUMP. ADVISED DISCONTINUATION OF THE INSULIN PUMP. THE BLOOD GLUCOSE LEVEL WAS NOT INCLUDED IN THE REPORT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651025 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-554WWB

    Patients

    Seq Age Sex Outcome Treatment
    1