BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 5686128 · Received May 27, 2016

    Report

    Report Number
    3004209178-2016-51149
    Event Type
    Malfunction
    Date Received
    May 27, 2016
    Date of Event
    May 10, 2016
    Report Date
    May 10, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    RELIABILITY ANALYSIS EVALUATED THREE OPENED/USED RESERVOIRS. INSPECTED THE RESERVOIR O-RINGS/STOPPER GROOVE FOR ANOMALIES AND NONE WERE FOUND. RAN BASAL, BOLUS LEAKING TESTS AND NO LEAKS WERE FOUND.

    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

    THE CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THE INSULIN PUMP HAD RESERVOIR LEAK DURING BOLUS. CUSTOMER'S BLOOD GLUCOSE AT TIME OF INCIDENT WAS UNKNOWN. CUSTOMER STATED THE RESERVOIR WAS USED. THE CUSTOMER STATED THE LEAK IS AT THE BACK OF THE RESERVOIR. THE CUSTOMER WAS EXPLAINED HOW TO FILLED THE RESERVOIR. THE CUSTOMER AGREED TO RETURN THE RESERVOIR BACK AND WE WILL SEND 2 T-PACKS OF RESERVOIRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341043 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR