BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 7085899 · Received December 6, 2017

    Report

    Report Number
    3005862821-2017-00129
    Event Type
    Injury
    Date Received
    December 6, 2017
    Date of Event
    October 29, 2017
    Report Date
    October 30, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841519007
    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 11/25/2014. THE STRIP LOT #D161201-2 WAS MANUFACTURED ON 12/01/2016 AND EXPIRED IN 12/2018. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS . OKB TESTED THE RETAIN STRIPS OF SAME BATCH FROM OUR WAREHOUSE WITH OUR STANDARFD METER AND CONTROL SOLUTION, THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 48/53 MG/DL; FOR LEVEL HIGH WERE 218/219 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) 2017 AT 1:00AM AFTER THE END USER EXPERIENCED SWEATING, SHAKING AND HAD A SEIZURE. HIS BLOOD GLUCOSE READING AT THE TIME OF THE MEDICAL EVENT WAS 120 MG/DL WHICH IS WITHIN NORMAL RANGE. THE END USER WAS TAKEN TO THE ER AND UPON ARRIVAL HIS BLOOD GLUCOSE READING WAS 56 MG/DL. THERE WAS NO TREATMENT GIVEN OR TEST PERFORMED DUE TO HIS LOW BLOOD GLUCOSE READING. AFTER AN HOUR IN THE ER THE END USER WAS DISCHARGED WITH A BLOOD GLUCOSE READING OF 110 MG/DL AND INSTRUCTED TO FOLLOW-UP WITH HIS PCP. NO ADDITIONAL DETAILS WERE PROVIDED IN REGARDS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868936 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51900 72500 - D161201-2 00384841519007

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention ACETAZOLAMIDE| GABAPENTIN| LANTUS| LISINOPRIL| NOVALOG