BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR

    MDR report key: 3981985 · Received August 5, 2014

    Report

    Report Number
    2032227-2014-06124
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE SENSOR GAVE INACCURATE READINGS. HE ALSO STATED THAT THERE WAS A CRACK IN THE TRANSMITTER. THE BLOOD GLUCOSE READING WAS 189 MG/DL. CUSTOMER STATED THAT THE READINGS WERE OFF BY OVER 200 POINTS. CUSTOMER WAS WEARING EXPIRED SENSORS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458079 SENSOR CGM MDS MEDTRONIC MINIMED MMT-7002C L033

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR