BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR

    MDR report key: 4846019 · Received June 15, 2015

    Report

    Report Number
    2032227-2015-19008
    Event Type
    Injury
    Date Received
    June 15, 2015
    Date of Event
    May 25, 2015
    Report Date
    May 27, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RELIABILITY ANALYSIS INSPECTED ONE OPENED/USED SENSORS AND PERFORMED BICARBONATE BUFFER TEST. THE SENSOR PASSED PER SPECIFICATIONS WITH ACCURATE 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. REFERENCE MANUFACTURER REPORT NUMBER: 2032227-2015-19009.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT HE HAD RECEIVED A SENSOR ERROR AND HAD A BLOOD GLUCOSE OF 36 MG/DL. CUSTOMER STATED THAT IT IS SUPPOSED TO ALARM HIM IF HE IS BELOW 100 MG/DL. CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS 127 MG/DL. CUSTOMER STATED THAT HE WAS UNABLE TO UPLOAD INTO (B)(4) PERSONAL. CUSTOMER STATED THAT THEY ARE UNABLE TO RUN THE TEST PLUG PROCEDURE. CUSTOMER COULDN'T SEE ANY PROBLEMS WITH THE TRANSMITTER. TROUBLESHOOTING WAS PERFORMED BUT WAS NOT COMPLETED BECAUSE THE CUSTOMER ALREADY REMOVED THE SENSOR. CUSTOMER WILL RECEIVE A REPLACEMENT TRANSMITTER, SENSOR, AND CANISTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388918 SENSOR CGM MDS MEDTRONIC MINIMED MMT-7002C C235

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR