BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3945136 · Received July 18, 2014

    Report

    Report Number
    2032227-2014-04511
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    ONE OPEN OR USED ENLITE SENSOR WAS INSPECTED AND BICARBONATE BUFFER TEST WAS PERFORMED, IT PASSED. NEEDLE COMPLAINT WAS NOT CONFIRMED DUE TO CUSTOMER DID NOT RETURN INSERTION NEEDLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A DISCREPANCY IN HIS SENSOR GLUCOSE LEVELS WHEN COMPARED TO HIS BLOOD GLUCOSE. THE SENSOR GLUCOSE READINGS WERE STATED TO BE 100 MG/DL OFF. THIS OCCURRED FOLLOWING THE CUSTOMER BLEEDING AT THE INSERTION SITE. THE CUSTOMER'S BLOOD GLUCOSE WAS 136 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423681 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A HG03SZ7

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR