BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR

    MDR report key: 3942751 · Received July 17, 2014

    Report

    Report Number
    2032227-2014-03975
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ONE OPENED AND USED SENSOR WAS INSPECTED AND A BICARBONATE BUFFER TEST WAS PERFORMED. THE SENSOR FAILED FOR LOW READINGS.

    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

    IT WAS REPORTED THAT THE SENSOR IS ALERTING SENSOR ERROR. CUSTOMER IS EXPERIENCING HIGH BLOOD GLUCOSE. CUSTOMER DID NOT WANT TO CALIBRATE UNTIL SHE TREATED THE HIGH. THE BLOOD GLUCOSE READING IS 180 MG/DL. DURING TROUBLESHOOTING, FOUND THAT CUSTOMER IS OVERTAPING THE SENSOR. THE SENSOR WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420216 SENSOR CGM MDS MEDTRONIC MINIMED MMT-7002C D184

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR