BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4773289 · Received May 14, 2015

    Report

    Report Number
    2032227-2015-14553
    Event Type
    Malfunction
    Date Received
    May 14, 2015
    Date of Event
    April 22, 2015
    Report Date
    April 23, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTED ONE OPENED AND USED SENSOR. PERFORMED BICARBONATE BUFFER TEST. SENSOR PASSED PER SPECIFICATION WITH ACCURATE READINGS.

    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT SHE HAD AN ISSUE WITH THE SENSOR. CUSTOMER STATED THAT THE NEEDLE HUB BROKE OFF INSIDE THE SERTER. CUSTOMER FOUND THAT THE NEEDLE HUB WENT INTO THE SERTER AND THE REST OF THE SENSOR REMAINED ON THE PEDESTAL. CUSTOMER'S BLOOD GLUCOSE WAS 250-298 MG/DL. CUSTOMER MENTIONED THAT SHE ALSO HAD AN ISSUE WITH BENT SENSOR CANNULAS BUT DID NOT WANT TO TROUBLESHOOT. REPLACEMENT SENSORS WILL BE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317446 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A HG0CFQP

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR