BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6652822 · Received June 20, 2017

    Report

    Report Number
    3005862821-2017-00051
    Event Type
    Injury
    Date Received
    June 20, 2017
    Date of Event
    February 26, 2017
    Report Date
    May 15, 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
    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 PDC ON 11/22/2012. THE STRIP LOT # D160517-1 WAS MANUFACTURED ON 05/17/2016 AND WILL BE EXPIRED IN 05/2018. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS. WE TESTED THE RETAIN STRIPS OF SAME BATCH #D160517-1, THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 50/48 MG/DL; FOR LEVEL HIGH WERE 231/239 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

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2017 BETWEEN 9:00 - 10:00 PM AFTER THE END USER RECEIVED A "HIGH" RESULT FROM HER PRODIGY DIABETES GLUCOSE METER. THE END USER STATED THAT SHE FELT EXHAUSTED AND COULD NOT STAND. THE END USER WAS TAKEN TO THE ER AND UPON ARRIVAL HER BLOOD GLUCOSE READING WAS 700 MG/DL. AT THIS POINT SHE RECEIVED FLUIDS AND INSULIN TO ASSIST IN STABILIZING HER BLOOD GLUCOSE LEVEL. AFTER TWO DAYS IN THE HOSPITAL THE END USER WAS DISCHARGED AND INSTRUCTED TO FOLLOW A DIET AND MAINTAIN HER BLOOD GLUCOSE LEVELS. NO ADDITIONAL INFORMATION WAS PROVIDED IN RELATIONS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433702 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. N/A 52800 - D160517-1

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R INVOKANA| JANUVIA| LEVEMIR 25 UNITS IN THE MORNING| METFORMIN| VICTOZA 1.2 UNITS AT LUNCH