BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4910986 · Received July 13, 2015

    Report

    Report Number
    3004209178-2015-73702
    Event Type
    Injury
    Date Received
    July 13, 2015
    Date of Event
    June 22, 2015
    Report Date
    June 22, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD BEEN EXPERIENCING HIGH BLOOD GLUCOSE AND NO DELIVERY ALARMS FOR THE PAST 2 WEEKS. CUSTOMER WAS ALSO EXPERIENCING SOME LOWS. CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS 26.0 MMOL/L. CUSTOMER'S CURRENT BLOOD GLUCOSE WAS 15.2 MMOL/L. CUSTOMER TREATED WITH AN INSULIN PEN. CUSTOMER HAD SOME BUBBLES IN THE RESERVOIR AND STATED THAT IT IS NORMAL FOR THEM TO SEE AIR BUBBLES IN THE RESERVOIR ON THE THIRD DAY OF USING THE SET AND RESERVOIR. CUSTOMER DECLINED TO ATTEMPT TO PRIME THE AIR BUBBLES OUT OF THE RESERVOIR DUE TO A SET CHANGE SCHEDULED FOR TODAY. CUSTOMER RAN A SELF TEST AND THE PUMP PASSED. CUSTOMER DECLINED TO HAVE THE PUMP REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452375 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other