BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 5143230 · Received October 10, 2015

    Report

    Report Number
    2032227-2015-56032
    Event Type
    Malfunction
    Date Received
    October 10, 2015
    Date of Event
    September 14, 2015
    Report Date
    September 14, 2015
    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
    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAS A STRONG SMELL OF INSULIN COMING FROM THE RESERVOIR COMPARTMENT. TROUBLESHOOTING INDICATED THAT THIS MAY BE DUE TO AN AIR BUBBLE LEAK IN THE RESERVOIR AND THAT THE RESERVOIR SHOULD BE CHANGED OUT. CUSTOMER INDICATED THAT THERE IS AN AIR BUBBLE IN THE RESERVOIR AND IN THE TUBING. CUSTOMER'S BLOOD GLUCOSE WAS OVER 135 MG/DL AT THE TIME OF INCIDENT. NO FURTHER INFORMATION WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672863 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR