BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6921503 · Received October 6, 2017

    Report

    Report Number
    3005862821-2017-00096
    Event Type
    Injury
    Date Received
    October 6, 2017
    Date of Event
    August 21, 2017
    Report Date
    August 22, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841518505
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    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 10/28/2016. THE STRIP LOT # D160307-1 WAS MANUFACTURED ON 03/07/2016 AND EXPIRED IN 03/2018. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS. WE TESTED THE RETAIN STRIPS OF D160309-1 WITH OUR IN HOUSE METER AND CONTROL SOLUTION, THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 63/63 MG/DL; FOR LEVEL HIGH WERE 248/246 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~80 MG/DL; LEVEL HIGH 210~310 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 AFTER THE END USER RECEIVED HIGHER THAN NORMAL BLOOD GLUCOSE RESULTS FROM HER PRODIGY DIABETES METER. THE CALLER ALSO STATED THAT THE DESICCANTS IN THE TEST STRIP VIAL ARE PINK WHICH INDICATES IMPROPER STORAGE AND THAT COULD ATTRIBUTE TO INCONSISTENT BLOOD GLUCOSE READINGS. THE END USER WOULD NOT DISCLOSE ANY INFORMATION IN REGARDS TO THIS MEDICAL EVENT AND REQUESTED THAT WE NOT CONTACT HER ANYMORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702429 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800 - D160307-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention