BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6351986 · Received February 23, 2017

    Report

    Report Number
    3005862821-2017-00018
    Event Type
    Injury
    Date Received
    February 23, 2017
    Date of Event
    January 25, 2017
    Report Date
    January 25, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 10/28/2016. THE STRIP LOT #D160425-1 WAS MANUFACTURED ON 04/25/2016 AND EXPIRED IN APR. 2018. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS . WE TESTED THE RETAIN STRIPS OF SAME BATCH, THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 59/58 MG/DL; FOR LEVEL HIGH WERE 246/255 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

    THE END USER REPORTED THAT HE SOUGHT MEDICAL ATTENTION ON (B)(6) 2017 AT 2:00AM AFTER RECEIVING A RESULT OF "HI" FROM THE PRODIGY DIABETES GLUCOSE METER. HE WAS SHAKING AND DID NOT FEEL WELL AND CALLED THE PARAMEDICS. THEY PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND RECEIVED A RESULT OF 114 MG/DL. THERE WAS NO TREATMENT ADMINISTERED BY THE PARAMEDICS. NO ADDITIONAL INFORMATION WAS PROVIDED IN RELATIONS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136020 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800 - D160425-1

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention DEPAKOTE| GABAPENTIN| HALDOL| KLONOPIN| LOPRESSOR| METFORMIN| MOBIC| PROZAC| ZOCOR