BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINILINK TRANSMITTER

    MDR report key: 3972411 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05161
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    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 CALLED STATING HE HAS BEEN GETTING MULTIPLE SENSOR ERRORS FOR THE LAST DAY AND A HALF. THIS IS UNIQUE TO THIS BOX OF SENSORS. HIS BLOOD GLUCOSE IS 43 MG/DL. HE STATED IT WAS LOW BECAUSE HE WAS NOT ALARMED BY HIS SENSOR. HE HAS TREATED BY EATING. HE DECLINED TROUBLE SHOOTING FOR LOW BLOOD GLUCOSE. THE TRANSMITTER PASSED THE TEST PLUG PROCEDURE. CUSTOMER WAS ADVISED THE TRANSMITTER IS FUNCTIONING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446762 MINILINK TRANSMITTER CGM MDS MEDTRONIC MINIMED MMT-7703NA A000307614

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention