BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4250856 · Received November 14, 2014

    Report

    Report Number
    2032227-2014-52434
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 17, 2014
    Report Date
    October 17, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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 THE CUSTOMER WAS EXPERIENCING LOW BLOOD GLUCOSE THROUGHOUT THE DAY. THE CUSTOMER ALSO REPORTED A HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER'S BLOOD GLUCOSE WAS 229 MG/DL AT THE TIME OF THE CALL. CUSTOMER ALSO REPORTED RECEIVING SENSOR ERROR AND LOST SENSOR ALARMS. CUSTOMER DECLINED TO TROUBLESHOOT FOR THEIR HIGH AND LOW BLOOD GLUCOSE. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737574 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR