BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OZO

    MDR report key: 4594131 · Received March 12, 2015

    Report

    Report Number
    3004209178-2015-41073
    Event Type
    Injury
    Date Received
    March 12, 2015
    Date of Event
    January 1, 2015
    Report Date
    February 28, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    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 SHE EXPERIENCED LOW BLOOD GLUCOSE. SHE BELIEVES SHE MAY HAVE OVER BOLUSED IN ERROR. BLOOD GLUCOSE VALUE WAS 46 MG/DL; SHE TREATED WITH FOOD. CUSTOMER STATED HER BLOOD GLUCOSE HAS BEEN LOW ON AND OFF; SHE WOULD WAKE UP FEELING LOW. AFTER DISCUSSING THE TROUBLESHOOT, SHE FEELS LOWS ARE DUE TO JUST NORMAL UPS AND DOWNS SHE HAS HAD WITH DIABETES AND NOT RELATED THE DEVICE. THE DRIVE SUPPORT CAP IS RECESSED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170382 OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR