BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4792058 · Received May 22, 2015

    Report

    Report Number
    3004209178-2015-58821
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    April 20, 2015
    Report Date
    May 3, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    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

    CUSTOMER REPORTED VIA PHONE, THE INSULIN PUMP HAD ALARMED NO DELIVER THREE TIMES AND WASN'T SURE WHY TWO OF THE ALARMS OCCURRED. CUSTOMER UNDERSTOOD ONE OF THE ALARMS OCCURRED BECAUSE THE DEVICE WAS OUT OF INSULIN. CUSTOMER DID NOT RECALL HIS BLOOD GLUCOSE LEVEL AT THE TIME OF EVENT. TROUBLESHOOTING WAS NOT POSSIBLE AS CUSTOMER WAS REPORTING A PAST EVENT. CUSTOMER WAS ADVISED TO MONITOR THE DEVICE AND CALL BACK WHEN ISSUE OCCURS TO PERFORM PROPER TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335022 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR