BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4233450 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48796
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    RELIABILITY ANALYSIS INSPECTED 2 OPENED/USED ENLITE SENSORS AND PERFORMED BICARBONATE BUFFER TEST DOP114-830. BOTH SENSORS PASSED WITH ACCURATE READINGS. UNABLE TO CONFIRM NEEDLE COMPLAINT DUE TO CUSTOMER DID NOT RETURNED INSERTION NEEDLE ONLY SENSOR. UNABLE TO CONFIRM ADHESIVE ANOMALY DUE TO SENSOR WAS RETURNED OPENED/USED.

    Description of Event or Problem · 1

    CUSTOMER'S HUSBAND REPORTED RECEIVING LARGE DIFFERENCES BETWEEN SENSOR GLUCOSE AND BLOOD GLUCOSE READINGS. CALLER REPORTED THAT THE INSULIN PUMP WENT INTO THRESHOLD SUSPEND WITH A SENSOR GLUCOSE READING OF 56 MG/DL AND A BLOOD GLUCOSE READING OF 172 MG/DL. BLOOD GLUCOSE LEVEL AT THE TIME OF THE CALL WAS 172 MG/DL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713519 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A B054U

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR