BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6735205 · Received July 24, 2017

    Report

    Report Number
    3005862821-2017-00071
    Event Type
    Injury
    Date Received
    July 24, 2017
    Date of Event
    June 19, 2017
    Report Date
    June 24, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE THE 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 (B)(6) DEPARTMENT AND SHIPPED TO PDC ON (B)(6) 2016. PATIENT'S STRIP LOT # D160420-1 WAS MANUFACTURED ON 04/20/2016 AND EXPIRED ON 04/20/2018. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS. WE TESTED THE RETAIN STRIPS FROM OUR WAREHOUSE (SAME STRIP LOT AS PATIENT'S STRIP, #D160420-1)/. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 55/58 MG/DL; FOR LEVEL HIGH WERE 238/239 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 8:00 - 9:00 PM AFTER THE END USER RECEIVED HIGHER THAN NORMAL BLOOD GLUCOSE RESULTS FROM HER PRODIGY DIABETES METER. THE END USER PERFORMED A BLOOD GLUCOSE TEST AND RECEIVED A RESULT OF 463 MG/DL AND PROCEEDED TO TAKE INSULIN BASED ON THE HIGHER READING. THE END USER'S BLOOD GLUCOSE DROPPED DOWN TO 50 MG/DL AND SHE BECAME UNRESPONSIVE. THE PARAMEDICS WERE CALLED AND SHE WAS TRANSPORTED TO THE ER. THE END USER WAS NOT ABLE TO RECALL ANY DETAILS RELATED TO ANY TREATMENTS OR BLOOD GLUCOSE TEST PERFORMED BY THE PARAMEDICS OR ER PERSONNEL. AFTER 4 HOURS IN THE ER THE END USER WAS DISCHARGED WITH A BLOOD GLUCOSE READING OF 125 MG/DL. NO ADDITIONAL DETAILS WERE PROVIDED IN RELATIONS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517505 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800 - D160420-1

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention