BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4183491 · Received October 18, 2014

    Report

    Report Number
    2032227-2014-40227
    Event Type
    Malfunction
    Date Received
    October 18, 2014
    Date of Event
    September 20, 2014
    Report Date
    September 20, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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

    IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS OF 96 MG/DL. THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED NO DELIVERY DURING MANUAL PRIME. TROUBLESHOOTING WAS DONE. THE CUSTOMER WAS ADVISED ON HOW TO CLEAR THE ALARM FROM THE INSULIN PUMP. THE CUSTOMER WAS ASKED TO DELIVER A FIVE UNIT PRIME FROM THE INSULIN PUMP. THE CUSTOMER REPORTED THAT INSULIN DID NOT EXIT. THE CUSTOMER WAS ADVISED TO PUSH INSULIN SLOWLY WITH A PLUNGER. THE CUSTOMER REPORTED THAT INSULIN DID EXIT WITH A LITTLE RESISTANCE. IT WAS REPORTED THAT THE RESERVOIR OF THE INSULIN OF THE INSULIN PUMP WAS OCCLUDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664121 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A HG00D1H

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR