BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4132014 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-30888
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 31, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THAT THE CUSTOMER HAD EXTREME PAIN AND SWELLING AFTER CHANGING THE INFUSION SET. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 500 MG/DL. CUSTOMER STATED THAT THE BELT CLIP BROKE AND THE BATTERY METER FLUCTUATES FROM FULL TO ONE BAR. CUSTOMER WAS ADVISED THAT THE PUMP CONDUCTS SEVERAL TESTS THROUGHOUT THE DAY AND WHEN THE PUMP IS GOING THROUGH THE TESTING, THE BATTERY INDICATOR MAY BE REDUCED AND WILL RETURN WHEN TESTS ARE COMPLETED. CUSTOMER STATED THAT SOMETIMES THE SET DOES NOT GO IN WHEN THE SERTER IS USED. CUSTOMER REPORTED THAT THE PUMP HAS A SCRATCH ON THE SCREEN BUT IT DOES NOT AFFECT THE READING OF THE DISPLAY. CUSTOMER WAS ASSISTED WITH TURNING OFF THE SENSOR FEATURE AND WAS ADVISED TO MONITOR THE PUMP. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610363 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR