BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3974259 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-88884
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ISSUES WITH THE INSULIN PUMP AND SENSOR READINGS. CUSTOMER STATES THAT HER SENSOR GLUCOSE AND BLOOD GLUCOSE VALUES ARE OFF. THE SENSOR GLUCOSE READING WAS 68 MG/DL AND THE BLOOD GLUCOSE WAS 285 MG/DL. CUSTOMER STATES THAT HE WAS GETTING THE CHANGE SENSOR ALARM, WHICH WAS CAUSING HIM TO CHANGE THE SENSORS BEFORE THE SIX DAY PERIOD. CUSTOMER ALSO MENTIONED HE HAS HIGH KEY TONES. CUSTOMER STATES THAT THEY ARE HAVING CALIBRATION ERRORS BUT IT WAS DISCOVERED THAT THEY WERE NOT CALIBRATING AT APPROPRIATE TIMES. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449772 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR