BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINILINK TRANSMITTER

    MDR report key: 4201306 · Received October 27, 2014

    Report

    Report Number
    2032227-2014-42434
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. PLEASE REFER TO MANUFACTURER'S REPORT NO. 2032227-2014-42453 AS IT REFERS TO THE SAME EVENT, BUT OF A DIFFERENT DEVICE. PLEASE REFER TO MANUFACTURER'S REPORT NO. 2032227-2014-42433 AS IT REFERS TO THE SAME EVENT, BUT OF A DIFFERENT DEVICE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED DISCREPANCIES BETWEEN HER SENSOR GLUCOSE AND BLOOD GLUCOSE READINGS. THE CUSTOMER'S BLOOD GLUCOSE WAS 286 MG/DL AND HER SENSOR GLUCOSE WAS 142 MG/DL. THE CUSTOMER STATED HER READINGS WERE ALWAYS OFF BY 100 POINTS. SHE ALSO REPORTED THAT HER CANNULA WAS NOT BENT. THE CUSTOMER ALSO REPORTED A PARAMEDIC VISIT FOR LOW BLOOD GLUCOSE. DATE OF ADMISSION WAS (B)(6) 2014. BLOOD GLUCOSE AT THE TIME THE PARAMEDICS ARRIVED WAS UNDER 17 MG/DL. THE CUSTOMER STATED SHE WAS NOT IN A VEHICULAR ACCIDENT. THE CUSTOMER STATED THAT HER INSULIN PUMP DID NOT SUSPEND, CAUSING HER TO HAVE LOW BLOOD GLUCOSE. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682860 MINILINK TRANSMITTER CGM MDS MEDTRONIC MINIMED MMT-7703NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR