BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3984567 · Received August 6, 2014

    Report

    Report Number
    3004209178-2014-90537
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 6, 2014
    Report Date
    July 6, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    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

    IT WAS REPORTED BY THE CUSTOMER THAT THEIR INSULIN PUMP WAS ALARMING NO DELIVERY. CUSTOMER STATES THAT THEY HAVE CHANGE THE RESERVOIR AND INFUSION SET, YET ISSUE HAS CONTINUED. DURING TROUBLESHOOTING, CUSTOMER WAS ASKED TO PERFORM A FIXED PRIME. CUSTOMER STATES THE INSULIN DID NOT EXIT AND THE DEVICE ALARMED NO DELIVERY. NEXT, CUSTOMER WAS ASKED TO REMOVE RESERVOIR AND PERFORM A MANUAL PRIME. CUSTOMER STATES THE INSULIN DID EXIT AND THE DEVICE DID NOT ALARM NO DELIVERY. ADVISED CUSTOMER THE ISSUE MIGHT BE AN OCCLUDED INSERTION SITE. ADVISED CUSTOMER TO REPLACE RESERVOIR AND SET. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 120 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459259 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR