BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4791081 · Received May 22, 2015

    Report

    Report Number
    3004209178-2015-58682
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    April 10, 2015
    Report Date
    April 10, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RESERVOIR EXPERIENCED AN AIR BUBBLES ANOMALY. THE CALLER STATED THAT, DURING THE FILL RESERVOIR PROCESS, AIR BUBBLES FORMED IN THE RESERVOIR THAT COULD NOT BE EXPELLED. THE CALLER STATED THAT EVEN WHEN THE RESERVOIR WAS FILLED WITHOUT ANY AIR BUBBLES, AIR BUBBLES WOULD FORM EVENTUALLY AFTER SOME TIME. THE CALLER DID NOT KNOW THE BLOOD GLUCOSE READING AND NO FURTHER DETAILS WERE GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336863 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A H9160435

    Patients

    Seq Age Sex Outcome Treatment
    1