BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4120042 · Received September 25, 2014

    Report

    Report Number
    2032227-2014-25876
    Event Type
    Malfunction
    Date Received
    September 25, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.PLEASE SEE MEDWATCH REPORT # 2032227-2014-29356.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SENSOR GLUCOSE AND BLOOD GLUCOSE READINGS HAD DISCREPANCIES, WHICH TRIGGERED THE INSULIN PUMP TO GO INTO THRESHOLD SUSPEND MODE. THE BLOOD GLUCOSE READING WAS 154 MG/DL. THE CUSTOMER STATED THAT THE INSULIN PUMP ALARMED ALL NIGHT AND SHE RECEIVED A SENSOR END MESSAGE, REQUIRING A NEW SENSOR. SHE REPORTED FALSE LOW GLUCOSE PREDICTIVE ALERTS. THE THRESHOLD SUSPEND WAS SET TO ENGAGE AT 60 MG/DL. SHE ALSO NOTED THAT THE SENSOR PREDICTED LOW BLOOD GLUCOSE WHEN HER BLOOD GLUCOSE READING WAS 204 MG/DL. THE BLOOD GLUCOSE READING AT THE TIME OF CALL WAS 108 MG/DL. ADVISED THE CUSTOMER THAT A FOLLOW UP WOULD BE SCHEDULED. SHE ALSO NOTED MILD SKIN IRRITATION AT THE INSERTION SITE, WHICH SHE DESCRIBED AS RED AND ITCHY. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597030 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR