BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4791058 · Received May 22, 2015

    Report

    Report Number
    3004209178-2015-59095
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    May 4, 2015
    Report Date
    May 4, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. 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 THERE WERE AIR BUBBLES IN THE RESERVOIR AND TUBING OF THE INFUSION SET. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. WHILE TROUBLESHOOTING, THE CUSTOMER STATED THAT THE SIZE OF THE AIR BUBBLES WAS 6 MM. THE CUSTOMER EXPLAINED THAT THE BUBBLES OCCURRED AFTER TWO HOURS. THE CUSTOMER WAS UNABLE TO PERFORM THE HIGH PRESSURE TEST. THE CUSTOMER STATED THERE WERE NO LEAKS DETECTED NOR WAS THERE FLUID IN THE INSULIN PUMP. THE CUSTOMER WAS ADVISED THAT THE RESERVOIRS WOULD BE REPLACED. THE CUSTOMER DID NOT RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336788 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A HG0D908

    Patients

    Seq Age Sex Outcome Treatment
    1