BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR

    MDR report key: 5041049 · Received August 29, 2015

    Report

    Report Number
    2032227-2015-37988
    Event Type
    Injury
    Date Received
    August 29, 2015
    Date of Event
    August 9, 2015
    Report Date
    August 10, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 VIA PHONE CALL, THE SENSOR READINGS WERE INACCURATE AND WERE TRIGGERING THE THRESHOLD SUSPEND FEATURE ON THE INSULIN PUMP WHEN BLOOD GLUCOSE WASN'T LOW. CUSTOMER'S BLOOD GLUCOSE WAS 480 MG/DL AND SENSOR READING WAS 51 MG/DL. CUSTOMER TREATED HER HIGH BLOOD GLUCOSE WITH THE INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED AND CUSTOMER WAS ADVISED TO MONITOR THE SENSOR GLUCOSE PERFORMANCE. THE SENSOR IS NOT RETURNING FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573213 SENSOR OZO OZO MEDTRONIC MINIMED MMT-7008

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other