BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4022223 · Received August 19, 2014

    Report

    Report Number
    3004209178-2014-95662
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Date of Event
    July 20, 2014
    Report Date
    July 20, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    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 THAT THERE WAS A LARGE DIFFERENCE IN SENSOR GLUCOSE VERSUS BLOOD GLUCOSE READING. SENSOR GLUCOSE LEVEL WAS 210 MG/DL WHILE BLOOD GLUCOSE LEVEL WAS 549 MG/DL AT THE TIME OF THE CALL. FOLLOWING THIS, THE CUSTOMER WAS UNABLE TO DELIVER ANY INSULIN DUE TO THE INSULIN PUMP RETURNING A NO DELIVERY ALARM. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499061 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS A2551NASJ

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR