BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4233488 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48846
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    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 THAT THE THRESHOLD SUSPEND ALARM KEEPS GOING OFF AND ALERTING THE CUSTOMER THAT THEY HE IS LOW WHEN IN REALITY HIS BLOOD GLUCOSE READINGS ARE REALLY HIGH. CUSTOMER'S BLOOD GLUCOSE READINGS AT THE TIME OF THE CALL WERE 252 MG/DL AND HAVE NOT TREATED. CUSTOMER STATED THAT THE SENSOR WAS READING 69 MG/DL. CUSTOMER ALSO MENTIONED NOTICING BENT CANNULAS IN THE PAST. CUSTOMER'S BLOOD GLUCOSE READINGS BY THE END OF THE CALL WERE 276 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713710 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A UNK7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR