BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUARDIAN REAL-TIME MONITIOR

    MDR report key: 3800813 · Received May 8, 2014

    Report

    Report Number
    2032227-2014-02128
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    November 6, 2013
    Report Date
    April 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT PASSED THE FUNCTIONAL TESTING, AND UPLOADED PROPERLY ON CARE LINK PRO. NO TIME FRAME UPLOADING ANOMALY WAS NOTED. THE REPORT SHOWS THAT THE BLOOD GLUCOSE WAS ENTERED PROPERLY ON (B)(6) 2014. THE LOW/HIGH ALARM TEST FUNCTIONED PROPERLY.

    Description of Event or Problem · 1

    THE PATIENT CALLED FOR ASSISTANCE WITH THE CARE LINK SOFTWARE. THE PATIENT THEN MENTIONED THAT SHE WAS TREATED BY THE PARAMEDICS LAST YEAR DUE TO BLOOD GLUCOSE LEVELS BELOW 40 MG/DL. THE PATIENT STATED SHE WAS IN A COMA, AND DID NOT FEEL OR HEAR ANY WARNINGS OF HYPOGLYCEMIA. THE PATIENT FELT STROKE-LIKE SYMPTOMS TEN DAYS LATER, AND WHEN SHE WENT TO THE EMERGENCY ROOM, SHE WAS DIAGNOSED WITH TIA. THE PATIENT FELT THAT THE GUARDIAN NEEDED TO BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279009 GUARDIAN REAL-TIME MONITIOR CGM MDS MEDTRONIC MINIMED CSS7100NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention