BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4223096 · Received November 4, 2014

    Report

    Report Number
    2032227-2014-47432
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    RELIABILITY ANALYSIS INSPECTED TWO OPENED OR USED ENLITE SENSORS AND PERFORMED BICARBONATE BUFFER TEST. ONE OF TWO SENSORS FAILED FOR LOW READINGS. TWO REMAINING SENSORS PASSED PER SPECIFICATIONS WITH ACCURATE READINGS. ALSO FOUND BOTH SENSORS CANNULAS WERE BENT. UNABLE TO CONFIRM CUSTOMERS RECEIVED SENSORS IN SAID CONDITION DUE TO CUSTOMER RETURNED OPENED AND USED. INSPECTED ONE INSERTION NEEDLE FOR BURRS AND HOOKS AND DULL NEEDLES TIP DEFECTS AND NONE WERE FOUND. INTRODUCER NEEDLE PASSED PER SPECIFICATION. UNABLE TO CONFIRM CUSTOMER'S COMPLAINT DUE TO CUSTOMER PARTIAL SENSOR THAT WAS MISSING ONE NEEDLE. NO SENSOR BREAK DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6), 2014, THE SENSOR TIP BROKE OFF AND THE INSULIN PUMP WAS ALARMING SENSOR ERROR. CUSTOMER'S SPOUSE ALSO STATED THERE WERE FOUR SENSORS THAT DID NOT HAVE GLUE. CUSTOMER'S SPOUSE STATED THE FIRST SENSOR HE ATTEMPTED TO INSERT THE NEEDLE STEM BROKE OFF. CUSTOMER'S BLOOD GLUCOSE WAS 146 MG/DL. CUSTOMER'S FATHER ALSO STATED THE SENSOR WAS CRIMPED OR BENT IN A 45 DEGREE ANGLE. TROUBLESHOOTING FOR ALARM WAS DONE. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705611 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A G184U

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR