BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3942821 · Received July 17, 2014

    Report

    Report Number
    2032227-2014-04431
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE SENSOR SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    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

    CUSTOMER COMPLAINED ABOUT SENSORS NOT FUNCTIONING PROPERLY. CUSTOMER STATED THAT HE HAD SOME PREVIOUS SENSORS THAT WERE NOT ADHERING AND HAD TO REMOVE BEFORE 6 DAYS OF USE. CUSTOMER ALSO REPORTED THAT HE HAD TO REMOVE THE LAST SENSOR AROUND THE SECOND DAY OF USE BECAUSE IT WAS NOT READING CORRECTLY; HE COULD NOT CALIBRATE AND RECEIVED ALARMS. CUSTOMER STATED THAT THE INSULIN PUMP ALARMED THRESHOLD SUSPEND DUE TO SENSOR GLUCOSE READING WAS BETWEEN 54 AND 43 BUT HIS BLOOD GLUCOSE WAS 90. DURING TROUBLESHOOT; CUSTOMER STATED THAT HE HAS NOTICED BENT CANNULAS ON SOME OF THE SENSORS HE REMOVES AND ALSO THAT HE HAS BEEN OVER CALIBRATING. LAST BLOOD GLUCOSE LEVEL 44 MG/DL; CUSTOMER TREATED WITH GLUCOSE TABLES AND FOOD. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419261 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR