BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE MMT-7008A

    MDR report key: 4141767 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33534
    Event Type
    Injury
    Date Received
    October 4, 2014
    Date of Event
    August 30, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF 1 OPENED AND USED ENLITE SENSOR SHOWED THAT IT FAILED PER SPECIFICATION DUE TO LOW READINGS. UNABLE TO PERFORM NEEDLE ANOMALY DUE TO CUSTOMER DID NOT RETURN NEEDLE SENSOR ONLY; ALSO FOUND CANNULA BENT. UNABLE TO CONFIRM CUSTOMER RECEIVED SENSOR IN SAID CONDITION DUE TO CUSTOMER RETURNED OPENED AND USED.

    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

    IT IS REPORTED THAT THE PATIENT EXPERIENCED A LOW BLOOD GLUCOSE LEVEL. LEVEL AT THE TIME WAS 30MG/DL. TROUBLE SHOOTING WAS CONDUCTED AND WE EXPLAINED THE POSSIBLE REASONS FOR A LOW BLOOD GLUCOSE LEVEL TO THE PATIENT. THE DEVICE IS NOT BEING RETURNED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621195 SENSOR ENLITE MMT-7008A OZO OZO MEDTRONIC MINIMED MMT-7008A E164U

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR