BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6309842 · Received February 7, 2017

    Report

    Report Number
    3005862821-2017-00012
    Event Type
    Injury
    Date Received
    February 7, 2017
    Date of Event
    December 30, 2016
    Report Date
    December 30, 2016
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. WE TESTED THE STANDBY CURRENT OF THE RETURNED METER, THE RESULT WAS 1.2UA. THE CRITERIA IS <55UA. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. WE TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND RETURNED STRIPS (STRIP LOT NUMBER: D150617-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 50/50 MG/DL, FOR LEVEL HIGH WERE 295/294 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. 4. WE TESTED OUR RETAIN STRIPS OF SAME BATCH (STRIP LOT NUMBER: D150617-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 59/58 MG/DL; FOR LEVEL HIGH WERE 271/261 MG/DL. THE CONTROL SOLUTION RANGES ARE: LEVEL LOW 25~70 MG/DL; LEVEL HIGH 210~310 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. OK BIOTECH REVIEWED THE MANUFACTURING RECORD OF THIS SUSPECTED DEVICE (METER SERIAL NUMBER # (B)(4)), THE METER WAS QUALIFIED AND RELEASED BY THE QUALITY CONTROL DEPARTMENT AND SHIPPED TO (B)(4) ON 01/24/2014. THE STRIP LOT #D150617-1 WAS MANUFACTURED ON 06/17/2015 AND WILL BE EXPIRED IN JUNE 17, 2017. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS . WE TESTED THE RETAIN STRIPS TEST OF SAME BATCH STRIPS (LOT#D150617-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 59/58 MG/DL; FOR LEVEL HIGH WERE 271/261 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

    DEVICES WERE RETURNED FROM PRODIGY DIABETES CARE ON 02/14//2017 AND AN INVESTIGATION RESULTS OF THE SUSPECT DEVICES WERE COMPLETED BY OK BIOTECH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE END USER SOUGHT MEDICAL ATTENTION ON (B)(6) 2016 BETWEEN 9:30 - 10:00AM AFTER RECEIVING HIGH BLOOD GLUCOSE TEST RESULTS FROM THE PRODIGY DIABETES GLUCOSE METER. THE END USER RECEIVED A BLOOD GLUCOSE READING OF 595 MG/DL AT THE TIME OF THE EVENT AND PROCEEDED TO TAKE 36 UNITS OF LANTUS. SHE PASSED OUT AND THE PARAMEDICS WERE CALLED AND THEY PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND RECEIVED A RESULT OF 22 MG/DL. THE END USER WAS TRANSPORTED TO THE ER AND RECEIVED IV FLUIDS BUT COULD NOT RECALL EXACTLY WHAT WAS ADMINISTERED. UPON DISCHARGE FROM THE ER THE END USER'S BLOOD GLUCOSE WAS 140 MG/DL. NO ADDITIONAL INFORMATION WAS PROVIDED IN REGARDS TO THE MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91617 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800- D150617-1

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention BUPROPION HC XL 150MG| CARVEDILOL 25MG| FLUOXETINE 20MG| HUMALOG| LANTUS| LEVOTHYROXINE 125MG| LISINOPRIL 40MG| PRILOSEC 20MG| ULORIC 40MG