BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6123824 · Received November 23, 2016

    Report

    Report Number
    3005862821-2016-00102
    Event Type
    Injury
    Date Received
    November 23, 2016
    Date of Event
    October 13, 2016
    Report Date
    October 13, 2016
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 (B)(6) 2013. 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

    END USER'S HUSBAND REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2016 AT 5:30 PM AFTER RECEIVING HIGH BLOOD GLUCOSE. RESULTS FROM THE PRODIGY DIABETES METER. END USER WAS SWEATING PROFUSELY AND UNCONSCIOUS, AT THIS POINT THE PARAMEDICS WERE CALLED. THE READING ON THE PRODIGY METER AT THE TIME OF THE EVENT WAS 110 MG/DL. PARAMEDICS PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND THE RESULT WAS 38 MG/DL. SHE WAS GIVEN ORANGE JUICE AND ANOTHER TEST WAS PERFORMED WITH A RESULT OF 68 MG/DL. THE END USER WAS TRANSPORTED TO THE ER AND WAS ADMINISTERED GLUCOSE INTRAVENOUSLY TO INCREASE HER BLOOD GLUCOSE LEVEL. UPON DISCHARGE THE END USER WAS INSTRUCTED TO FOLLOW UP WITH HER PCP AND CONTINUE TO MONITOR HER BLOOD GLUCOSE. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776029 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention