BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6088678 · Received November 9, 2016

    Report

    Report Number
    3005862821-2016-00098
    Event Type
    Injury
    Date Received
    November 9, 2016
    Date of Event
    October 4, 2016
    Report Date
    October 4, 2016
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 (B)(4) 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 8:00 PM AFTER RECEIVING A READING OF 22 MG/DL ON HIS PRODIGY DIABETES METER. THE END USER WAS SWEATING PROFUSELY, INCOHERENT AND FAINTED AND THE PARAMEDICS WERE CALLED. THE PARAMEDICS PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND EXPLAINED THAT HIS BLOOD LEVEL WAS LOW. THE CALLER WAS UNABLE TO RECALL THE ACTUAL RESULT. THE END USER WAS TRANSPORTED TO THE ER AND WAS GIVEN A GLUCOSE SUBSTANCE BY THE PARAMEDICS TO RAISE HIS BLOOD LEVEL. UPON ARRIVAL TO THE ER HIS BLOOD GLUCOSE LEVEL WAS IN THE 20'S AND HE RECEIVED AND IV AND A HAM SANDWICH TO INCREASE HIS BLOOD LEVEL. HE REMAINED IN THE ER FOR 24 HOURS AND NO OTHER TREATMENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739301 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other ASPIRIN| DAILY MULTI VITAMIN| HYDROCHLOROT| KLOR-CON| LANTUS| LISINOPRIL| MAGNESIUM| METOPROLOL| PHENAZEPAM| POTA CHLORIDE| SERTRALINE| SIMVASTATIN