BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3852316 · Received June 5, 2014

    Report

    Report Number
    2032227-2014-02906
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV
    Reporter Occupation
    PATIENT

    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. 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.

    Additional Manufacturer Narrative · 1

    RELIABILITY ANALYSIS INSPECTED FIVE OPENED/USED ENLITE SENSORS AND PERFORMED VISUAL INSPECTION. FOUND ONE OF FIVE SENSOR CANNULAS TO BE BROKEN. THE REMAINING SENSORS PERFORMED BICARBONATE BUFFER TEST, AND FOUND ONE OF FOUR FAILED PER SPECIFICATION WITH LOW READINGS. THREE REMAINING SENSORS PASSED PER SPECIFICATION WITH ACCURATE READINGS. UNABLE TO CONFIRM THE ADHESIVE ANOMALY DUE TO THE PRODUCT BEING RETURNED OPENED/USED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HIS SENSOR IS NOT WORKING. CUSTOMER STATED THAT THREE WEEKS AGO HE TOOK OUT HIS SENSOR AND CANNULA WAS SHORTER. BLOOD GLUCOSE LEVEL WAS 101MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329369 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR