BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4153739 · Received October 8, 2014

    Report

    Report Number
    2032227-2014-35427
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    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 REPORTS TO HAVE RECEIVED NO DELIVERY ALARMS AND AIR BUBBLES IN RESERVOIR. CUSTOMER'S BLOOD GLUCOSE IS UNKNOWN. CUSTOMER WAS ADVISED TO ALLOW INSULIN THIRTY TO FORTY-FIVE MINUTES TO ADJUST TO ROOM TEMPERATURE AFTER BEING REFRIGIRATED AND TO NOT ROLL INSULIN VIAL BETWEEN HIS HANDS. CUSTOMER WAS NOT ABLE TO CONTINUE TROUBLESHOOTING. CUSTOMER WILL CALL BACK TO CONTINUE TROUBLESHOOTING. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631859 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR