BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4181479 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39577
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    August 1, 2014
    Report Date
    September 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    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

    CUSTOMER REPORTED THAT SHE HAD TO CHANGE OUT HER INFUSION SETS PREMATURELY. THE CUSTOMER STATED SHE WAS RECEIVING NO DELIVERY ALARMS ON HER INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE WAS 116 MG/DL. THE CUSTOMER ALSO INQUIRED ABOUT RETURNING HER SENSORS. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660003 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A HG05Q0Y

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR