BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3933440 · Received July 14, 2014

    Report

    Report Number
    2032227-2014-03791
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 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

    A COMPLETE ANALYSIS AND TESTING OF 1 OPENED AND USED ENLITE SENSOR SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. HOWEVER, UNABLE TO CONFIRM NEEDLE COMPLAINT DUE TO THE CUSTOMER DID NOT RETURN INSERTION NEEDLE WITH THE ENLITE SENSOR.

    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 REPORTED HAVING ISSUES WITH THE SENSORS. CUSTOMER REPORTED THAT SHE WAS BLEEDING AT INSERTION SITE. SHE INSERTED A NEW SENSOR SINCE SHE HAD PREVIOUS ISSUES WITH BLOOD ON THE SITE. NEW SENSOR IS CAUSING THE INSULIN PUMP TO ALARM MULTIPLE SENSOR ERRORS. TROUBLESHOOTING WAS PERFORMED ON BOTH SENSORS AND TROUBLESHOOTING DETERMINED ISSUE MIGHT BE ON THE TRANSMITTER. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 91 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410426 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A B014U

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR