BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML MMT-332A

    MDR report key: 8666020 · Received June 4, 2019

    Report

    Report Number
    2032227-2019-11301
    Event Type
    Malfunction
    Date Received
    June 4, 2019
    Date of Event
    May 29, 2019
    Report Date
    June 4, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    IT WAS REPORTED THAT THEY HAD ISSUE WITH AIR BUBBLES IN HER RESERVOIRS. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER HAD ISSUE WITH INSULIN FLOW BLOCKED AND HAD DISCARDED SEVERAL TUBES. THE CUSTOMER DECLINED TROUBLESHOOTING. THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459116 RESERVOIR 3ML MMT-332A PUMP, INFUSION FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A

    Patients

    Seq Age Sex Outcome Treatment
    1