BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 6158548 · Received December 9, 2016

    Report

    Report Number
    2032227-2016-48955
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Date of Event
    November 13, 2016
    Report Date
    November 13, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER'S FATHER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED NO DELIVERY. THE ALARM WAS CAUSED BY AN INFUSION SET/RESERVOIR CONNECTION. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 248 MG/DL. THE DEVICE WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815356 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A HG1500F

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR