BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4103484 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26359
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 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

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    DURING A FOLLOW UP CALL IT WAS REPORTED THAT THE CUSTOMER HAD ISSUES WITH THE SENSOR, WEAK SIGNAL AND LOST SIGNAL ALARMS, AND THE INSULIN PUMP GOING INTO THRESHOLD SUSPEND MODE. THE CALLER STATED THAT THE SENSOR GLUCOSE WOULD READ 110 MG/DL WHEN THE CUSTOMER'S BLOOD GLUCOSE WAS 220 MG/DL. THE CALLER STATED THAT THE READINGS WERE OFF BY MORE THAN 100 POINTS IN EITHER DIRECTION. THE CALLER STATED THAT NO MATTER WHERE THE CUSTOMER PLACED THE SENSORS THEY WOULD GET WEAK SIGNAL AND LOST SENSOR ALARMS. THE ANOMALY OCCURRED WITH DIFFERENT BATCHES OF SENSORS. THE OTHER ISSUE WAS THAT THE THRESHOLD SUSPEND WOULD NOT ALLOW THE CUSTOMER TO CONTROL IT; THERE WAS NO WAY TO ADJUST IT. REGARDLESS OF THE CUSTOMER'S ACTIONS OR COMMENDS, THE THRESHOLD SUSPEND ALARM KEPT REPEATING. THE CONTROL WAS NOT ACCESSIBLE BY THE CUSTOMER. THEY COULD NOT BLOCK OR CHANGE. TROUBLESHOOTING WAS DECLINED. AT THE TIME OF THE PHONE CALL THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583690 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR