BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4243967 · Received November 11, 2014

    Report

    Report Number
    2032227-2014-50363
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 14, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS OF ABOUT 349 MG/DL. THE CUSTOMER REPORTED A BLANK DISPLAY ON THE INSULIN PUMP. THE CUSTOMER FURTHER REPORTED THAT THERE WERE NO ALERTS PRIOR TO THE BLANK DISPLAY ON THE INSULIN PUMP. THE CUSTOMER ALSO REPORTED AN UNEXPECTED RESTART BY THE INSULIN PUMP. THE CUSTOMER ALSO REPORTED RECEIVING AN EXTERNAL RAM CRC ERROR FROM THE INSULIN PUMP. TROUBLESHOOTING WAS DONE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726125 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR