BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 5307604 · Received December 17, 2015

    Report

    Report Number
    2032227-2015-75728
    Event Type
    Malfunction
    Date Received
    December 17, 2015
    Date of Event
    November 12, 2015
    Report Date
    November 30, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    RELIABILITY ANALYSIS INSPECTED FOUR OPENED/USED ENLITE SENSORS AND FOUND ALL FOUR NEEDLES SEPARATED FROM THE SENSOR BASE. UNABLE TO CONFIRM THAT THE CUSTOMER RECEIVED THE SENSORS IN SAID CONDITION DUE TO THE PRODUCT BEING RETURNED OPENED/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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL OF A SENSOR ANOMALY. THE CUSTOMER'S BLOOD GLUCOSE READING WAS UNKNOWN. THE CUSTOMER STATED THAT HE TOOK 4-5 SENSORS WITH HIM TO TRAVEL WHILE IN (B)(6). THE CUSTOMER STATED THAT HE USES THE SOF-SENSOR AND THE CONFIGURATION OF THE STEM BEING 90 DEGREES, THE STEM FAILS. THE CUSTOMER STATED THAT HE HAD THE SENSORS PACKED IN HIS LUGGAGE. THE CUSTOMER STATED THAT WHENEVER HE TOOK A SENSOR OUT, THE STEM SOMEHOW BROKE OFF FROM THE SENSOR. THE CUSTOMER WILL BE SENT REPLACEMENT SENSORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835658 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR