BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 5143244 · Received October 10, 2015

    Report

    Report Number
    2032227-2015-56007
    Event Type
    Malfunction
    Date Received
    October 10, 2015
    Date of Event
    November 5, 2014
    Report Date
    October 6, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    RELIABILITY ANALYSIS INSPECTED 3 OPENED/USED ENLITE SENSORS AND PERFORMED VISUAL INSPECTION AND FOUND 1 OF 3 SENSORS WITH NEEDLE BENT INSIDE SENSOR BASE, SECOND SENSOR SEPARATED FROM NEEDLE HUB AND THIRD SENSOR IS MISSING NEEDLE HUB. IT IS UNKNOWN IF THE CUSTOMER RECEIVED SENSORS IN SAID CONDITION DUE TO RETURNING THEM OPENED/USED. TWO SENSORS PERFORMED BICARBONATE BUFFER TEST AND SENSORS PASSED PER SPECIFICATIONS WITH ACCURATE READINGS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL THAT HE EXPERIENCED SENSOR READING DISCREPANCIES. CUSTOMER STATED THAT THE SENSOR WAS READING 368 MG/DL AND BLOOD GLUCOSE WAS 268 MG/DL. CURRENTLY THE SENSOR GLUCOSE WAS 62 MG/DL AND HIS BLOOD GLUCOSE WAS 89 MG/DL. CUSTOMER STATED THAT THE ISSUES STARTED WHEN HE STARTED USING THE SENSORS FROM THE CURRENT BOX AND THE BOX MIGHT BE DEFECTIVE. THE SENSORS WERE REPLACED AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673368 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR