BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6053232 · Received October 25, 2016

    Report

    Report Number
    3005862821-2016-00090
    Event Type
    Injury
    Date Received
    October 25, 2016
    Date of Event
    September 22, 2016
    Report Date
    September 22, 2016
    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 (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

    IT WAS REPORTED THAT THE END USER SOUGHT MEDICAL ATTENTION ON (B)(6) 2016 AT 6:30 AM AFTER RECEIVING A BLOOD GLUCOSE READING OF 47MG/DL. THE END USER WAS UNRESPONSIVE AND SWEATING AND THE PARAMEDICS WERE CALLED. THE PARAMEDICS TESTED HIS BLOOD GLUCOSE WITH THEIR METER AND THE RESULTS WERE 35MG/DL AND 175 MG/DL. GLUCOSE ALONG WITH AN IV OF FLUID WAS ADMINISTERED TO AID IN INCREASING HIS BLOOD LEVELS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705473 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention INSULIN - (B)(6) UNITS AT LUNCH| INSULIN - (B)(6) UNITS AT DINNER| INSULIN - (B)(6) UNITS IN THE MORNING