BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 6117266 · Received November 21, 2016

    Report

    Report Number
    2032227-2016-43535
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    October 27, 2016
    Report Date
    February 22, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP RECEIVED WITH CRACKED BATTERY TUBE THREAD, BROKEN BELT CLIP SLOT, BROKEN RESERVOIR TUBE LIP, CRACKED RESERVOIR TUBE, CRACKED CASE NEAR DISPLAY WINDOW CORNERS, CRACKED ON DISPLAY WINDOW AND MINOR SCRATCHES ON DISPLAY WINDOW NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP IS DAMAGED. CUSTOMER'S BLOOD GLUCOSE WAS 69 MG/DL AT THE TIME OF INCIDENT. TROUBLESHOOTING FOUND THAT THE DISPLAY SCREEN IS CRACKED AND THE BATTERY CAP DOES NOT CLOSE CORRECTLY DUE TO A BROKEN RESERVOIR LOCK. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS. NO FURTHER DETAILS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766829 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754WWP

    Patients

    Seq Age Sex Outcome Treatment
    1