BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4221765 · Received November 3, 2014

    Report

    Report Number
    2032227-2014-46716
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 REPORTED THAT THE RESERVOIR HAD OCCLUSION. CUSTOMER'S BLOOD GLUCOSE WAS 20.3 MMOL/L. CUSTOMER STATED HAD PROBLEMS WITH INFUSION SETS. CUSTOMER THINKS IT WAS BECAUSE OF THE CANNULA. TROUBLESHOOTING WAS DONE. CUSTOMER UNABLE TO CONTINUE TO TROUBLESHOOT. ADVISED THE CUSTOMER THE RESERVOIR AND SETS WOULD BE REPLACED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703334 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A HG03ZTK

    Patients

    Seq Age Sex Outcome Treatment
    1