BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 7312423 · Received March 5, 2018

    Report

    Report Number
    3005862821-2018-00017
    Event Type
    Injury
    Date Received
    March 5, 2018
    Date of Event
    February 1, 2018
    Report Date
    February 4, 2018
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841519007
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 06/06/2013. THE STRIP LOT # D170721-1 WAS MANUFACTURED ON 07/21/2017 AND EXPIRED IN 07/21/2019. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS. WE TESTED THE RETAIN STRIPS OF SAME BATCH FROM OUR WAREHOUSE, WITH OUR IN HOUSE METER AND IN HOUSE CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 55/61 MG/DL; FOR LEVEL HIGH WERE 259/249 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~85 MG/DL; LEVEL HIGH 200~310 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) 2018 AT 4:35 PM AFTER THE END USER ALLEGED THAT HE RECEIVED HIGHER THAN NORMAL BLOOD GLUCOSE RESULTS FROM HIS PRODIGY DIABETES METER. THE END USER PERFORMED A BLOOD GLUCOSE TEST WITH HIS PRODIGY METER AND THE READING WAS 562 MG/DL. THERE WERE NO SIGNIFICANT SYMPTOMS BUT OUT OF CONCERN FOR THE HIGH BLOOD GLUCOSE READING THE PARAMEDICS WERE IMMEDIATELY CALLED. UPON ARRIVAL THEY PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND THE RESULT WAS 144 MG/DL. DUE TO THE FACT THAT HIS BLOOD GLUCOSE READING WAS WITHIN NORMAL RANGE THIS DID NOT WARRANT ANY TREATMENT OR TRANSPORT TO THE ER. NO ADDITIONAL DETAILS WERE PROVIDED IN REGARDS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155977 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51900 73200 - D170721-1 00384841519007

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention AMLODIPINE| ASPRIN| BESYLATE| CREON| GLIPIZIDE| JANUVIA| LYRICA| METFORMIN| TABAVITE| VIBERZI