BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4143016 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-30221
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ONE OPENED AND USED ENLITE SERTER WAS INSPECTED AND THE INSTRUCTION TEST WAS PERFORMED USING A NEW LAB ENLITE SENSOR ALONG WITH RUBBER SKIN. THE ENLITE SERTER FAILED PER SPECIFICATION DUE TO THE NEEDLE HUB WAS STUCK INSIDE OF THE ENLITE SERTER CATCH ARM.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNK 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 INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE SENSOR DID NOT RELEASE FROM THE INSERTER. THE BLOOD GLUCOSE READING WAS 411 MG/DL. SHE STATED THAT THE FOLD OVER FLAP WAS NOT DISLODGED BEFORE PLACING THE SENSOR INTO THE INSERTER. CUSTOMER WAS ADVISED ON THE INSERTION PROCESS. CUSTOMER REPORTED THAT THE BLOOD GLUCOSE WAS HIGH DUE TO EATING RECENTLY AND STRESS AND THAT SHE HAD TREATED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603571 SENSOR ENLITE OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention