BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6970902 · Received October 24, 2017

    Report

    Report Number
    3005862821-2017-00108
    Event Type
    Injury
    Date Received
    October 24, 2017
    Date of Event
    September 15, 2017
    Report Date
    September 22, 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
    MI, 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 NOV. 12, 2015. THE STRIP LOT # D160516-1 WAS MANUFACTURED ON 05/16/2016 AND EXPIRED IN MAY 2018. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS . OK BIOTECH TESTED THE RETAIN STRIPS OF LOT#D160516-1 WITH IN HOUSE METER AND CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 50/49 MG/DL; FOR LEVEL HIGH WERE 231/239 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 12:00PM AFTER THE END USER RECEIVED HIGHER THAN NORMAL READINGS FROM HER PRODIGY DIABETES METER. THE END USER WAS UNRESPONSIVE, MUMBLING AND SWEATING ACCOMPANIED WITH SEVERAL HIGH BLOOD GLUCOSE RESULTS - 397MG/DL, 477MG/DL AND 430 MG/DL. THE PARAMEDICS WERE CALLED AND UPON ARRIVAL THEY PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND THE RESULT WAS 327 MG/DL. THE END USER WAS TRANSPORTED TO THE ER AND ADMINISTERED TREATMENT TO ASSIST IN LOWERING HER BLOOD GLUCOSE BUT THE CALLER COULD NOT RECALL AS TO WHAT WAS GIVEN. AFTER 12 HOURS IN THE ER THE END USER WAS DISCHARGED. NO ADDITIONAL DETAILS WERE PROVIDED IN REGARDS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753332 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800 - D160516-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention LEVEMIR| NOVALOG