BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4132066 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-30913
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 1, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    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

    CUSTOMER REPORTED RECEIVING SEVERAL NO DELIVERY ALARMS. THE CUSTOMER ALSO REPORTED HAVING AIR BUBBLES. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. THE CUSTOMER STATED THE AIR BUBBLES IN HIS RESERVOIR WAS LARGE. HE ALSO STATED HE DID NOT REWIND HIS INSULIN PUMP WITH THE RESERVOIR IN PLACE. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611817 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC MINIMED MMT-332A HG03GE1

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR