BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4252056 · Received November 14, 2014

    Report

    Report Number
    2032227-2014-52754
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    March 25, 2014
    Report Date
    April 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ANALYSIS INSPECTED 4 OPENED/USED ENLITE SENSORS AND PERFORMED BICARBONATE BUFFER TEST PER (B)(4). 1 OF 4 SENSORS FAILED FOR LOW READINGS. 3 REMAINING SENSORS PASSED PER SPEC. WITH ACCURATE READINGS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE SENSORS WERE NOT FUNCTIONING PROPERLY. CUSTOMER REPORTED HAVING A BLOOD GLUCOSE LEVEL OF 50 MG/DL. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP WENT INTO THRESHOLD SUSPEND. BLOOD GLUCOSE LEVEL AT THE TIME OF THE CALL WAS 125 MG/DL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736617 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A B144U

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR