BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6593349 · Received May 26, 2017

    Report

    Report Number
    3005862821-2017-00038
    Event Type
    Injury
    Date Received
    May 26, 2017
    Date of Event
    April 17, 2017
    Report Date
    April 17, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE DEVICE WAS NOT RETURNED TO OK BIOTECH, THEREFORE, WE WERE UNABLE TO PERFORM FURTHER TESTING ON THE SUSPECTED DEVICE. OK BIOTECH REVIEWED THE MANUFACTURING RECORD OF THIS SUSPECTED DEVICE (METER SERIAL NUMBER # (B)(4)), AND THE METER WAS QUALIFIED AND RELEASED BY THE QUALITY CONTROL DEPARTMENT AND SHIPPED TO PDC ON (B)(6) 2012. THE STRIP LOT #D160613-1 WAS MANUFACTURED ON 06/13/2016 AND EXPIRED IN 06/2018. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS . WE TESTED THE RETAIN STRIPS OF SAME BATCH (LOT #D160613-1), THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 60/62 MG/DL; FOR LEVEL HIGH WERE 235/236 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~80 MG/DL; LEVEL HIGH 190~290 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS . WE ARE UNABLE TO CONFIRM THE COMPLAINT BECAUSE DEVICE WAS NOT RETURNED AND NO FURTHER INFORMATION FROM CUSTOMER HAS BEEN RECEIVED, THIS MATTER HAS TO BE CLOSED OUT WITH UNDETERMINED ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2017 AFTER RECEIVING VARIED RESULTS FROM HER PRODIGY DIABETES GLUCOSE METER. THE END USER'S METFORMIN HAD RECENTLY BEEN CHANGED FROM 2000 MG/DL TO 500 MG/DL DAILY. THE END USER WAS DIZZY WITH BLURRY VISION AND LATER PASSED OUT. HER BLOOD GLUCOSE READING AT THE TIME OF THE MEDICAL EVENT WAS 112 MG/DL. THE PARAMEDICS WERE CALLED AND PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND THE RESULT WAS 79 MG/DL. THE END USER WAS INSTRUCTED TO EAT PEANUT BUTTER AND DRINK A SODA TO ASSIST IN STABILIZING HER BLOOD GLUCOSE. NO ADDITIONAL DETAILS WERE PROVIDED IN RELATIONS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377234 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800 - D160613-1

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Required Intervention