BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 5777890 · Received July 8, 2016

    Report

    Report Number
    3005862821-2016-00041
    Event Type
    Injury
    Date Received
    July 8, 2016
    Date of Event
    May 20, 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
    TN, 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 1.2UA. 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 63/62 MG/DL,FOR LEVEL HIGH ARE 285/280 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

    OUR IMPORTER, (B)(4) RECEIVED A CALL ON 06/06/2016 REPORTING A MEDICAL INTERVENTION THAT OCCURRED ON (B)(6) 2016 AT 7:30PM. PATIENT'S DAUGHTER ((B)(6)) CALLED IN STATING THAT PATIENT ((B)(6)) WAS OUT OF IT. PATIENT WAS DISPLAYING SYMPTOMS OF SLURRED SPEECH, SLEEPINESS, COULD NOT CONTROL BODILY FUNCTIONS AND CLAMMY SKIN. THE READING ON THE PRODIGY METER AT THE TIME OF THE EVENT WAS 39MG/DL. PATIENT'S NORMAL BLOOD GLUCOSE READING AROUND THE TIME OF DAY OF THE EVENT IS BETWEEN 170-230MG/DL. PARAMEDICS WERE CALLED APPROXIMATELY 10 MINUTES AFTER TESTING WITH THE PRODIGY METER. PATIENT WAS GIVEN SUGAR WATER AND CHOCOLATE BY ((B)(6)) WHILE WAITING ON PARAMEDICS TO ARRIVE. PARAMEDICS ARRIVED WITHIN 30 MINUTES AND TESTED PATIENT'S BLOOD GLUCOSE WITH RESULTS OF 169MG/DL ON ONE HAND AND 189MG/DL ON THE OTHER HAND. APPROXIMATELY 30 MINUTES PASSED BETWEEN TESTING WITH THE PRODIGY METER AND THE PARAMEDIC'S METER. PRODIGY SENT REPLACEMENT AND PREPAID ENVELOPE REQUESTING RETURN OF SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432403 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention GABAPENTIN 300 MG 3 TIMES