BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6676216 · Received June 29, 2017

    Report

    Report Number
    3005862821-2017-00053
    Event Type
    Injury
    Date Received
    June 29, 2017
    Date of Event
    May 3, 2017
    Report Date
    May 24, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. 1. WE TESTED THE STANDBY CURRENT OF RETUNED DEVICE, TEST RESULT WAS 11.7¿A. THE CRITERIA IS <55¿A. PASS. 2. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. 3. WE TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND RETURNED STRIPS (STRIP LOT NUMBER:D161102-2). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 49/48 MG/DL, FOR LEVEL HIGH WERE 221/231 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~80 MG/DL; LEVEL HIGH 190~290 MG/DL. ALL RESULTS WERE WITHIN OF THE ACCEPTANCE RANGE. PASS . 4.WE TESTED THE SAME PATIENT'S BACTH OF RETAIN STRIPS TEST FROM OUR WAREHOUSE (STRIP LOT NUMBER:D161102-2). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 59/60 MG/DL; FOR LEVEL HIGH WERE 241/237 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 .

    Additional Manufacturer Narrative · 1

    BECAUSE DEVICE WAS NOT RETURNED TO OK BIOTECH, THEREFORE, WE WERE UNABLE TO PERFORM FURTHER TESTING ON THE SUSPECTED DEVICE. 1. 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 09/14/2016. 2. THE STRIP LOT # D161102-2 WAS MANUFACTURED ON 11/02/2016 AND EXPIRED IN 11/02/2018. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS . 3. WE TESTED THE RETAIN STRIPS(SAME BATCH AS PATIENT'S STRIPS) FROM OUR WAREHOUSE, THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 65/62 MG/DL; FOR LEVEL HIGH WERE 248/246 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

    THIS IS A SUPPLEMENTAL REPORT TO INITIAL REPORT 3005862821-2017-00053 TO SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICES. DEVICES WERE RETURNED FROM PRODIGY DIABETES CARE ON 06/29//2017 AND AN INVESTIGATION RESULTS OF THE SUSPECT DEVICES WERE COMPLETED BY OK BIOTECH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2017 AT 4:00 AM AFTER THE END USER WAS RECEIVING HIGH BLOOD GLUCOSE READINGS FROM HER PRODIGY DIABETES METER. THE END USER WAS SWEATING AND NOT FEELING WELL. HER BLOOD GLUCOSE READING AT THE TIME OF THE MEDICAL EVENT WAS 146 MG/DL. THE PARAMEDICS WERE CALLED AND PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND THE RESULT WAS 55 MG/DL THE END WAS GIVEN AN UNKNOWN LIQUID DRINK AND TRANSPORTED TO THE ER. THE END USER COULD NOT RECALL WHAT TREATMENT WAS ADMINISTERED WHILE AT THE ER. AFTER 5 - 6 HOURS AT THE ER THE END USER WAS DISCHARGED AND INSTRUCTED TO FOLLOW-UP WITH HER PCP. NO FURTHER DETAILS WERE PROVIDED IN RELATIONS TO THIS MEDICAL EVENT DUE TO THE FACT THAT THE END USER COULD NOT RECALL MANY OF THE DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458514 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51900 73200-D161102-2

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention