BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 5605345 · Received April 25, 2016

    Report

    Report Number
    3004209178-2016-43037
    Event Type
    Malfunction
    Date Received
    April 25, 2016
    Date of Event
    April 18, 2016
    Report Date
    April 18, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Additional Manufacturer Narrative · 1

    RELIABILITY ANALYSIS EVALUATED ONE OPENED/USED RESERVOIR. INSPECTED THE SNAP-CAP AND SEPTUM FOR ANOMALIES AND NONE WERE FOUND. RAN OCCLUSION TESTING AND NO OCCLUSIONS WERE NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THEY HAD NO DELIVERY ALARM. CUSTOMER'S BLOOD GLUCOSE AT TIME OF INCIDENT WAS UNKNOWN. THE CUSTOMER STATED THAT HE HAD TO COMPLETE SET CHANGE 3 TIMES BEFORE IT FINALLY WORKED. THE CUSTOMER STATED THE PUMP IS NOW BACKED TO NORMAL AND WORKING, BLOOD GLUCOSE LEVELS ARE ALWAYS WITHIN RANGE. THE CUSTOMER WAS EXPLAINED THAT IT MAY HAVE BEEN DUE TO OCCLUSION BETWEEN SETS/RESERVOIRS. THE CUSTOMER WAS ADVISED TO CALL IN ORDER TO DO TROUBLESHOOTING. CUSTOMER WAS ADVISED THAT WE ARE SENDING T-PACK OF RESERVOIR AND INFUSION AS REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261335 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A

    Patients

    Seq Age Sex Outcome Treatment
    1