BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6379752 · Received March 6, 2017

    Report

    Report Number
    3005862821-2017-00022
    Event Type
    Injury
    Date Received
    March 6, 2017
    Date of Event
    February 8, 2017
    Report Date
    February 8, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 12/18/2012. THE STRIP LOT #D150720-2 WAS MANUFACTURED ON 07/20/2015 AND EXPIRED IN 07/2017. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS . WE TESTED THE RETAIN STRIPS OF THE SAME BATCH STRIP (LOT#D150720-2), THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 66/64 MG/DL; FOR LEVEL HIGH WERE 287/287 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 25~70 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 AT 12:30PM AFTER THE END USER RECEIVED A BLOOD GLUCOSE READING IN THE 500'S FROM THE PRODIGY DIABETES GLUCOSE METER. THE END USER WAS NOT EXPERIENCING ANY RELEVANT SYMPTOMS AND HIS NORMAL BLOOD GLUCOSE LEVEL AROUND THIS TIME OF THE DAY IS 64 MG/DL. THE END USER WAS TAKEN TO THE ER BY A FAMILY MEMBER AFTER RECEIVING THE FOLLOWING INCONSISTENT RESULTS - 500'S, 319 MG/DL AND 41 MG/DL. UPON ARRIVAL TO THE ER HIS BLOOD GLUCOSE WAS IN THE 300S. HE RECEIVED INSULIN TO ASSIST WITH STABILIZING HIS BLOOD GLUCOSE LEVEL. AFTER SEVERAL HOURS IN THE ER HE WAS DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED IN RELATIONS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164672 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 54800 - D150720-2

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention ALLOPURINOL 100MG| FENOFIBRATE 160MG| FISH OIL 1200MG| LEVOTHYROXINE 112MG| LOSARTAN 50MG (X2)| METFORMIN 500MG (X2 A DAY)| VITAMIN D 5000 UNITS