BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 5818402 · Received July 24, 2016

    Report

    Report Number
    3005862821-2016-00044
    Event Type
    Injury
    Date Received
    July 24, 2016
    Date of Event
    May 24, 2016
    Report Date
    June 8, 2016
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. THE STANDBY CURRENT TEST IS 1.5UA. THE CRITERIA IS <55UA. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND IN HOUSE STRIPS (STRIP LOT NUMBER: D150923-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW ARE 64/65 MG/DL, FOR LEVEL HIGH ARE 265/272 MG/DL. THE CONTROL SOLUTION RANGES ARE: LEVEL LOW 25~70 MG/DL; LEVEL HIGH 210~310 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS.

    Description of Event or Problem · 1

    (B)(4). PATIENT ((B)(6)) CALLED IN STATING THAT HE PASSED OUT. THE READING ON THE PRODIGY METER AT THE TIME OF THE EVENT WAS 121MG/DL. PATIENT'S NORMAL GLUCOSE READING AROUND THE TIME OF DAY OF THE EVENT IS 130MG/DL. PARAMEDICS WERE CALLED 15 MINUTES AFTER PATIENT TESTED WITH THE PRODIGY METER. PATIENT WAS GIVEN HONEY WHILE WAITING ON PARAMEDICS TO ARRIVE. PARAMEDICS ARRIVED 12 MINUTES AFTER BEING CALLED. PARAMEDICS PERFORMED A GLUCOSE TEST WITH THEIR METER WITH A RESULT OF 28MG/DL. APPROXIMATELY 27 MINUTES PASSED BETWEEN TESTING WITH THE PRODIGY METER AND THE PARAMEDIC'S METER. PARAMEDICS TREATED PATIENT WITH D50.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471307 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D150804-2

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention HYDRALAZINE -25 MG 3 TIMES PER DAY