BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6921374 · Received October 6, 2017

    Report

    Report Number
    3005862821-2017-00098
    Event Type
    Injury
    Date Received
    October 6, 2017
    Date of Event
    September 7, 2017
    Report Date
    September 8, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384840503021
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 (B)(4) ON 05/26/2015. THE STRIP LOT # D160720-1 WAS MANUFACTURED ON 07/20/2016 AND EXPIRED IN 07/2018. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS. WE TESTED THE RETAIN STRIPS TEST OF SAME BATCH#D160720-1 WITH IN HOUSE METER AND CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 59/61 MG/DL; FOR LEVEL HIGH WERE 230/228 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 AT 10:30 AM AFTER THE END USERS PRODIGY DIABETES METER WAS NOT OPERATING PROPERLY AND HE WAS UNABLE TO OBTAIN AN APPROPRIATE READING. THE END USER EXPERIENCED A LOW BLOOD GLUCOSE SEIZURE ACCOMPANIED WITH A READING OF 62 MG/DL. THE PARAMEDICS WERE CALLED AND UPON ARRIVAL THEY PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND THE RESULT WAS 42 MG/DL. THE END USER WAS GIVEN AN IV AND DEXTROSE INJECTION ALONG WITH BEING TRANSPORTED TO THE ER. SIMULTANEOUSLY HE RECEIVED ANOTHER DEXTROSE INJECTION AND IV SALINE. A BLOOD GLUCOSE TEST WAS PERFORMED AS WELL AS EXAMINING HIS POTASSIUM LEVELS. AT THE TIME OF THIS CALL THE END USER WAS CURRENTLY STILL IN THE HOSPITAL AND NO ADDITIONAL DETAILS WERE PROVIDED IN REGARDS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703886 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 50302 52800 - D160720-1 00384840503021

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization