BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE MMT-7008A

    MDR report key: 4033017 · Received August 25, 2014

    Report

    Report Number
    2032227-2014-10770
    Event Type
    Injury
    Date Received
    August 25, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 23, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTED ONE OPENED AND USED SENSOR. PERFORMED BICARBONATE BUFFER TEST. SENSOR PASSED PER SPECIFICATION WITH ACCURATE READINGS.

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ISSUES WITH SENSOR GLUCOSE VERSES BLOOD GLUCOSE DIFFERENCES. THE BLOOD GLUCOSE READING WAS 109 MG/DL. TROUBLESHOOTING WAS DONE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514758 SENSOR ENLITE MMT-7008A OZO OZO MEDTRONIC MINIMED MMT-7008A C264U

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR