BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4260179 · Received November 18, 2014

    Report

    Report Number
    2032227-2014-54493
    Event Type
    Malfunction
    Date Received
    November 18, 2014
    Date of Event
    October 21, 2014
    Report Date
    October 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE ISSUES WITH SENSORS. CUSTOMER STATED THAT THERE WAS DISCREPANCY ON SENSOR GLUCOSE READINGS VERSUS BLOOD GLUCOSE READINGS. THE CUSTOMER'S BLOOD GLUCOSE WAS AT 94 MG/DL. THE CUSTOMER STATED THEY RECEIVED THRESHOLD SUSPEND ON THEIR INSULIN PUMP. THE CUSTOMER WAS ASSISTED WITH TROUBLE SHOOTING AND WAS EDUCATED ON HOW THE SENSOR GLUCOSE AND BLOOD GLUCOSE READINGS WORK ON THEIR INSULIN PUMP. IT WAS FOUND THAT THE SENSOR WAS BENT A LITTLE BIT. CUSTOMER WILL RESTART THE SENSOR. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746744 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A HG06CT5

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR