BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR

    MDR report key: 4241470 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-50523
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 12, 2014
    Report Date
    October 12, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    P980022
    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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S BLOOD GLUCOSE LEVEL AND SENSOR GLUCOSE LEVEL WERE SIGNIFICANTLY DIFFERENT. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 151 MG/DL AND HIS SENSOR WAS REPORTING FALSE LOW BLOOD GLUCOSE READINGS. STANDARD TROUBLESHOOTING WAS PERFORMED. IT WAS DISCOVERED THAT THE CUSTOMER'S SENSOR WAS BENT. THE CUSTOMER WAS ADVISED TO CHANGE THE SENSOR. THE PRODUCT IS BEING RETURNED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722801 SENSOR OZO OZO MEDTRONIC MINIMED MMT-7002C F274

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR