BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4183196 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-40076
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    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

    NO BLOOD GLUCOSE LEVELS REPORTED. THE CUSTOMER REPORTED A NO DELIVERY ALARM FROM THE INSULIN PUMP DURING PRIME. TROUBLESHOOTING WAS DONE. THE CUSTOMER WAS ASKED TO CHANGE THE ENTIRE INFUSION SET INCLUDING THE RESERVOIR OF THE INSULIN PUMP. THE CUSTOMER WAS ABLE TO PRIME WITHOUT ISSUE. THE NO DELIVERY ALARM WAS RESOLVED BY A COMPLETE INFUSION SET CHANGE. THE CUSTOMER WAS ADVISED THAT THE RESERVOIR OF THE INSULIN PUMP WAS OCCLUDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660863 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR