BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4801274 · Received May 28, 2015

    Report

    Report Number
    3004209178-2015-59795
    Event Type
    Malfunction
    Date Received
    May 28, 2015
    Date of Event
    May 5, 2015
    Report Date
    May 6, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THE INSULIN PUMP ALARM NO DELIVERY DURING BASAL, BOLUS, FIXED PRIME. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN MG/DL. AFTER THE TROUBLESHOOTING WAS DONE, CUSTOMER WAS ADVISED TO REINSERT THE RESERVOIR AND RUN MANUAL PRIME UNTIL AT LEAST 5.0 UNITS. CUSTOMER REPORTED THAT THE INSULIN EXITS WITH MANUAL PRIMES. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP IS WORKING AS DESIGNED. CUSTOMER WAS ADVISED THAT THE ALARM WAS CAUSED BY SET/RESERVOIR OCCLUSION. CUSTOMER WAS ADVISED THE WE WOULD SEND REPLACEMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347516 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR