BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 3881675 · Received May 29, 2014

    Report

    Report Number
    3005862821-2014-00018
    Event Type
    Injury
    Date Received
    May 29, 2014
    Date of Event
    April 26, 2014
    Report Date
    April 28, 2014
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    (B)(4) RECEIVED A CALL ON (B)(6) 2014 REPORTING A MEDICAL INTERVENTION THAT OCCURRED ON (B)(6) 2014 AT 12:00 NOON. PT (B)(6) CALLED IN STATING THE REASON FOR THE INTERVENTION WAS BECAUSE SHE RECEIVED BLOOD GLUCOSE READING OF 66 MG/DL NO PRODIGY METER AND STARTED TO SWEAT AND BECOME UNCONSCIOUS. PT'S HUSBAND CALLED PARAMEDICS IN 5 MINUTES AND AT THE SAME TIME GIVE HER SOME JUICE AND SOME HONEY. PARAMEDICS CAME IN 10 MINUTES AND PERFORMED A BLOOD GLUCOSE TEST WITH A RESULT OF 20 MG/DL. PT'S NORMAL BLOOD GLUCOSE READING RECOMMENDED BY THE DOCTOR IS 110-120.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317298 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention