BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6844234 · Received September 6, 2017

    Report

    Report Number
    3005862821-2017-00094
    Event Type
    Injury
    Date Received
    September 6, 2017
    Date of Event
    August 2, 2017
    Report Date
    August 9, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841518505
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, 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 (B)(6) DEPARTMENT AND SHIPPED TO PDC ON (B)(6) 2016. THE STRIP LOT # D161011-1 WAS MANUFACTURED ON OCT. 11/2016 AND EXPIRED IN OCT. 2018. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS . BECAUSE PATIENT DID NOT RETURN HIS STRIPS, WE TESTED THE RETAIN STRIPS OF SAME BATCH IN OUR WAREHOUSE. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 65/64 MG/DL; FOR LEVEL HIGH WERE 244/246 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 2:00 PM AFTER THE END USER RECEIVED LOWER THAN NORMAL BLOOD GLUCOSE RESULTS. THE END USER EXPERIENCED DIZZINESS ACCOMPANIED WITH A LOW BLOOD GLUCOSE READING OF 52 MG/DL. THE PARAMEDICS WERE CALLED AND PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND THE RESULT WAS 90 MG/DL. NO TREATMENT WAS ADMINISTERED AND NOR WAS THE END USER TRANSPORTED TO THE ER DUE TO HIS BLOOD GLUCOSE READING WAS WITHIN THE NORMAL RANGE. NO ADDITIONAL DETAILS WERE PROVIDED IN REGARDS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625968 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800 - D161011-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention DOXAZOSIN 4 MG TWICE A DAY,| HALOPERIDOL 2 MG ONCE AT NIGHT,| LANTUS 12 UNITS ONCE A DAY.| LOSARTAN 100 MG ONCE DAILY,| SYNTHROID 50 MG ONE AM,