BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4183139 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-40149
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    TWO OPENED AND USED SENSORS WERE INSPECTED AND NO DEFECTS WERE NOTED ON THE INTRODUCER NEEDLE. THE INTRODUCER NEEDLE PASSED PER SPECIFICATIONS. NO INSERTION ANOMALY COULD BE CONFIRMED AS THE SENSORS WERE RETURNED SEPARATE FROM THE SENSOR BASE. ONE NEEDLE WAS MISSING.

    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

    CUSTOMER REPORTED THE FIRST NIGHT HE STARTED USING THE SENSORS, THERE WAS BLOOD AT THE INSERTION SITE AND THE READINGS WERE INACCURATE. THE SECOND NIGHT, THE SENSOR WOULD NOT PUNCTURE THE SKIN. HE EVENTUALLY WAS ABLE TO INSERT THE SENSOR MANUALLY. CUSTOMER'S CURRENT BLOOD GLUCOSE IS 212 MG/DL. THE FAULTY SENSORS ARE BEING REPLACED. CUSTOMER DECLINED TROUBLESHOOTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660579 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A HG074WR

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR