BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4820196 · Received June 4, 2015

    Report

    Report Number
    3004209178-2015-62770
    Event Type
    Malfunction
    Date Received
    June 4, 2015
    Date of Event
    May 18, 2015
    Report Date
    May 18, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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. 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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED NO DELIVERY. THE CUSTOMER'S BLOOD GLUCOSE WAS 169 MG/DL. THE CUSTOMER CONFIRMED THE ISSUE DID NOT RESULT IN A SERIOUS INJURY OR HOSPITALIZATION. WHILE TROUBLESHOOTING, THE CUSTOMER ATTEMPTED TO PERFORM A 5 UNIT FIXED PRIME, BUT INSULIN DID NOT EXIT. THE CUSTOMER WAS ADVISED TO REMOVE THE RESERVOIR FROM THE INSULIN PUMP, DISCONNECT AND RECONNECT THE RESERVOIR AND INFUSION SET AND THE TUBING CONNECTOR AND THEN PUSH INSULIN SLOWLY THROUGH THE TUBING. THE CUSTOMER REPORTED THAT INSULIN EXITED THE TUBING. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WAS WORKING AS DESIGNED. THE CUSTOMER WAS ADVISED THAT THE ALARM HAD BEEN CAUSED BY AN OCCLUSION RELATED TO THE RESERVOIR OR INFUSION SET. THE CUSTOMER WAS ADVISED TO CALL BACK IF FURTHER ISSUES OCCURRED. THE CUSTOMER WAS INFORMED THAT THE RESERVOIR AND INFUSION SET WOULD BE REPLACED. THE CUSTOMER DID NOT RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361829 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A HG0EEBU

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR