BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE MMT-7008A

    MDR report key: 4011412 · Received August 14, 2014

    Report

    Report Number
    2032227-2014-08066
    Event Type
    Injury
    Date Received
    August 14, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    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 A MISCOMMUNICATION BETWEEN INSULIN PUMP AND SENSOR. IT WAS REPORTED THAT THERE WAS REPEATED COMPLAINT FROM CUSTOMER REGARDING INSULIN PUMP'S READING OF SENSOR GLUCOSE VS BLOOD GLUCOSE DIFFERENCES. BLOOD GLUCOSE: 264. SENSOR GLUCOSE: 70. PERCENT DIFFERENCE OF EVENT: 73.5%. OVERALL MAD%: 19.9. CAL FACTOR IS TRENDING ABOVE THE OPTIMAL LEVEL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486877 SENSOR ENLITE MMT-7008A OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR