BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6204328 · Received December 27, 2016

    Report

    Report Number
    3005862821-2016-00115
    Event Type
    Injury
    Date Received
    December 27, 2016
    Date of Event
    November 12, 2016
    Report Date
    November 12, 2016
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 08/14/2013. THE STRIP LOT #D6151127-1 WAS MANUFACTURED ON 11/27/2015 AND EXPIRED IN 11/2017. WE TESTED THE RETAIN STRIPS(STRIP LOT NUMBER:D6151127-1), THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 54/56 MG/DL; FOR LEVEL HIGH WERE 239/235 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 . OK BIOTECH RECEIVED NO OTHER COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS. 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 THE END USER SOUGHT MEDICAL ATTENTION ON (B)(6) 2016 AT 12:00 PM AFTER RECEIVING INCONSISTENT HIGH READINGS FROM THE PRODIGY DIABETES GLUCOSE METER. THE END USER VISITED HIS PCP AFTER CONCERNS WITH HIGH GLUCOSE RESULTS. HIS GLUCOSE READING AT THE TIME OF THE MEDICAL EVENT WAS 311 MG/DL. THE END USER WAS NOT EXPERIENCING ANY OBVIOUS SYMPTOMS. UPON ARRIVAL TO HIS DOCTOR'S OFFICE HIS BLOOD GLUCOSE WAS 177 MG/DL AND NO TREATMENT WAS ADMINISTERED. HE WAS INSTRUCTED TO TAKE FARXIGA ONCE A DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856616 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 72500-D6151127-1

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention APORVASTATIN 40MG ONCE A DAY| BAYER ASPIRIN 80MG 1X DAILY| GEMFIBROZIL 600MG TWICE A DAY| GLIMEPIRIDE 2MG TWICE A DAY| LISINOPRIL 5MG ONCE A DAY| METFORMIN 1000MG TWICE A DAY