BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OYC

    MDR report key: 5417697 · Received February 8, 2016

    Report

    Report Number
    2032227-2016-01645
    Event Type
    Malfunction
    Date Received
    February 8, 2016
    Date of Event
    January 23, 2016
    Report Date
    January 24, 2016
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF 2 OPENED AND USED ENLITE SENSORS FOUND THE SENSORS FAILED PER SPECIFICATIONS ALSO FOUND BOTH SENSOR CANNULAS WERE BENT; UNABLE TO CONFIRM IF THE CUSTOMER RECEIVED THE SENSORS IN SAID CONDITION DUE TO THE CUSTOMER RETURNED OPENED AND USED.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THEIR SENSOR DISPLAYING WRONG READINGS OF SENSOR AND BLOOD GLUCOSE. THE PATIENT'S BLOOD GLUCOSE WAS 6 MMOL/L AT THE TIME OF THE CALL. THE CUSTOMER WAS ASSISTED WITH TROUBLE SHOOTING AND WAS INFORMED THAT THE SENSOR NEEDS TO BE REPLACED. THE CUSTOMER WAS EDUCATED ON THE PROPER SITE AND INSERTION TECHNIQUE OF THE SENSOR TO AVOID ANY ISSUES IN THE FUTURE. THE CUSTOMER WAS SENT A REPLACEMENT SENSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74945 OYC OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1