BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 7062437 · Received November 27, 2017

    Report

    Report Number
    3005862821-2017-00116
    Event Type
    Injury
    Date Received
    November 27, 2017
    Date of Event
    October 4, 2017
    Report Date
    October 4, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 04/22/2013. THE STRIP LOT # D160919-1 WAS MANUFACTURED ON 09/19/2016 AND EXPIRED IN 09/2018. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS. WE TESTED THE RETAIN STRIPS OF SAME BATCH FROM OUR WAREHOUSE,WITH OUR IN HOUSE METER AND CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 69/67 MG/DL; FOR LEVEL HIGH WERE 260/257 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 AT 12:00 PM AFTER THE END USER RECEIVED HIGHER THAN NORMAL BLOOD GLUCOSE READINGS FROM HER PRODIGY DIABETES METER. THE END USER PERFORMED A BLOOD GLUCOSE TEST WITH A READING OF 416 MG/DL. SHE HAD NO SIGNIFICANT SYMPTOMS BUT OUT OF CONCERN FOR THE HIGH READING THE PARAMEDICS WERE CALLED. UPON ARRIVAL THE PARAMEDICS PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND THE RESULT WAS 250 MG/DL. NO TREATMENT WAS WARRANTED AND THERE WAS NO REASON TO TRANSPORT THE END USER TO THE ER BECAUSE HER BLOOD GLUCOSE LEVEL WAS WITHIN NORMAL RANGE. NO ADDITIONAL DETAILS WERE PROVIDED IN REGARDS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841586 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800 - D160919-1

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Required Intervention