BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3942839 · Received July 17, 2014

    Report

    Report Number
    2032227-2014-04450
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    May 16, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE RELIABILITY ANALYSIS INSPECTED 6 OPENED OR USED SENSORS AND PERFORMED BICARBONATE BUFFER TEST PER (B)(4). THE 2 OF 6 SENSORS FAILED PER SPECIFICATIONS. THE 1 OF 2 SENSORS FAILED FOR LOW READINGS SECOND SENSOR DAMAGED TUBING SEPARATED FROM CANNULA. THE 4 REMAINING SENSORS PASSED WITH ACCURATE READINGS. THE UNIT WAS UNABLE TO PERFORM OR REPRODUCE SKIN IRRITATION IN LAB.

    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 EXPERIENCING IRRITATION AT THE SENSOR SITE. THE BLOOD GLUCOSE WAS 121 MG/DL. CUSTOMER STATED THAT THE SITE SHOWS SIGNS OF INFECTION, AND THAT THE SITE IS ITCHY, RED AND SWOLLEN. SHE STATED THAT THE ITCHINESS LASTED SEVERAL HOURS AND THAT THE BUMP LASTED ABOUT A DAY. CUSTOMER REPORTED THAT SHE DOES WASH HER HANDS AND CLEAN THE SITE PRIOR TO SET CHANGES. SHE STATED THAT THE CURRENT SITE DID NOT SHOW SIGNS OF INFECTION BUT THAT IT HAD BEEN A RECURRENT ISSUE. CUSTOMER ALSO REPORTED RECEIVING A CALIBRATION ERROR. THE SENSOR CANNULA WAS BENT UPON REMOVAL. THE SENSORS WERE NOT EXPIRED. SHE STATED THAT THERE WAS NO INCORRECT ENTRY OF A BLOOD GLUCOSE READING OR ANY DELAYED ENTRY FOR CALIBRATION. CUSTOMER IS FOLLOWING CALIBRATION PROTOCOL. CUSTOMER ALSO RECEIVED A CHANGE SENSOR ALARM. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419234 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A E284U

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR