BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4161928 · Received October 10, 2014

    Report

    Report Number
    2032227-2014-36123
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    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 A NO DELIVERY ALARM AND IT IS NOW GOING OFF EVERY 3 OR 4 MINUTES. CUSTOMER TRIED CHANGING EVERYTHING OUT ALREADY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 210 MG/DL. CUSTOMER WAS ASSISTED IN PERFORMING A 5.0U FIXED PRIME BUT THE INSULIN DID NOT EXIT. CUSTOMER TRIED TO PUSH INSULIN SLOWLY THROUGH THE TUBING AND REPORTED THAT THE INSULIN EXITED THE TUBING. CUSTOMER REPORTED THAT THE INSULIN EXITS WITH THE MANUAL PRIME. CUSTOMER WAS ADVISED THAT THE PUMP WAS WORKING AS DESIGNED. IT WAS EXPLAINED THAT THE ALARM WAS CAUSED BY SET/RESERVOIR OCCLUSION. CUSTOMER RECEIVED ANOTHER NO DELIVERY ALARM AFTER TROUBLESHOOTING. CUSTOMER CHANGED OUT HER INSULIN AND RESERVOIR. CUSTOMER STATED THAT SHE GOT THE FIRST ALARM WHEN SHE WAS SLEEPING. CUSTOMER ALSO HAD THE BLACK CIRCLE ON HER PUMP. CUSTOMER WAS INFORMED THAT SHE NEEDS TO HAVE THE INSULIN AT ROOM TEMPERATURE NOT IN THE REFRIGERATOR. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644104 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A H9074981

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR