BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3980716 · Received August 5, 2014

    Report

    Report Number
    2032227-2014-05950
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 4, 2014
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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. 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

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED CALIBRATION ERROR. THE CUSTOMER'S BLOOD GLUCOSE WAS 46 MG/DL. THE CUSTOMER STATED THAT THEY DID NOT KNOW WHY IT WAS SO LOW. THE CUSTOMER REFUSED TROUBLESHOOTING FOR THE LOW BLOOD GLUCOSE BECAUSE THEY WERE TREATING IT WITH GLUCOSE TABS. THE CUSTOMER HAD ALREADY CHANGED THE SENSOR SO NO TROUBLESHOOTING COULD BE PERFORMED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458595 SENSOR ENLITE OZO OZO MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR