BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE MMT-7008A

    MDR report key: 4170094 · Received October 14, 2014

    Report

    Report Number
    2032227-2014-37741
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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 HAVING LOW BLOOD GLUCOSE LEVELS AND WAS OBSERVED AT THE SCENE BY THE LOCAL EMS. CUSTOMER'S BLOOD GLUCOSE READING WAS 176 MG/DL. CUSTOMER STATES THE SIGNIFICANT EVENTS LEADING TO THE ADMISSION WERE OW BLOOD GLUCOSE LEVELS - PUMP SUSPENDED AS DESIGNED. BLOOD GLUCOSE VALUE AT THE TIME OF ADMISSION IS UNKNOWN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648918 SENSOR ENLITE MMT-7008A OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR