BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4212875 · Received October 25, 2014

    Report

    Report Number
    2032227-2014-43300
    Event Type
    Malfunction
    Date Received
    October 25, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IS IT 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

    IT WAS REPORTED THAT THE CUSTOMER HAD A REPLACED PUMP AND THE AIR BUBBLES ARE STILL AN ISSUE IN THEIR RESERVOIR. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 214 MG/DL. THE TROUBLE SHOOTING WAS DONE. THE CUSTOMER'S WAS ADVISED TO DISCONNECT AT QUICK RELEASE AND DELIVERED A 5 UNIT FIXED PRIME UNTIL AIR BUBBLES ARE LONGER VISIBLE. THE PATIENT'S WAS ADVISED TO CHANGED FIXED PRIME AMOUNT BACK TO APPROPRIATE PRIME CANNULA AMOUNT FOR THEIR INFUSION SET. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680402 RESERVOIR 3ML FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332 HG082GM

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR