BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR

    MDR report key: 4251661 · Received November 14, 2014

    Report

    Report Number
    2032227-2014-52777
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 18, 2014
    Report Date
    October 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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

    INSPECTED 1 OPENED/USED SENSOR AND PERFORMED BICARBONATE BUFFER TEST. SENSOR FAILED PER SPECIFICATIONS DUE TO LOW READINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 50 MG/DL. THE CUSTOMER TREATED HIS LOW BLOOD GLUCOSE LEVEL BY EATING CARBS. THE CUSTOMER RECEIVED AN ERROR FROM HIS SENSOR. STANDARD TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER REMOVED AND REPLACED THE SENSOR. THE PRODUCT IS BEING RETURNED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738546 SENSOR OZO OZO MEDTRONIC MINIMED MMT-7002C E224

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other