BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 3885171 · Received June 19, 2014

    Report

    Report Number
    3004209178-2014-85961
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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 THAT THE RESERVOIR WAS USED UP BUT NONE OF THE INSULIN WAS EVER DELIVERED TO THE CUSTOMER'S BODY. HE STATED THAT HE CHANGED THE INFUSION SET TO CHECK FOR AIR BUBBLES AND FOUND RUBBER RINGS AT THE END OF THE RESERVOIR. THERE WAS A SET CHANGE AND A PRIME WAS RUN. THE CUSTOMER SAID THE PRIME RAN FOR AN EXTENSIVE PERIOD OF TIME AND THE PUMP PUSHED OUT MOST OF THE INSULIN FROM THE RESERVOIR BUT HE ONLY SAW ONE DROP COME OUT OF THE TUBING. THERE WAS NEITHER A LEAK NOR WAS MOISTURE PRESENT ON THE INSULIN PUMP. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360743 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR