BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 7812108 · Received August 24, 2018

    Report

    Report Number
    3005862821-2018-00040
    Event Type
    Injury
    Date Received
    August 24, 2018
    Date of Event
    July 21, 2018
    Report Date
    August 3, 2018
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384840518858
    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 11/29/2011. THE STRIP LOT # D170609-2 WAS MANUFACTURED ON JUNE 09, 2017 AND EXPIRED ON JUNE 09, 2019. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS. WE TESTED THE RETAIN STRIPS (LOT# D170609-2) WITH OUR IN HOUSE METER AND CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 59/64 MG/DL; FOR LEVEL HIGH WERE 248/244 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~85 MG/DL; LEVEL HIGH 200~310 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

    REPORTER ALLEGED ON (B)(6) 2018 AT 1400 THE END-USER REQUIRED MEDICAL INTERVENTION DUE TO HYPOGLYCEMIA. REPORTER STATED THAT THE PRODIGY METER READ 80 MG/DL BUT THAT THE END-USER WAS SHAKING, SWEATING AND UNABLE TO SPEAK. END-USER DID EAT A BOLOGNA SANDWICH AND CAKE FOR LUNCH AS WELL AS TAKING 10 UNITS OF PRESCRIBED NOVOLOG. PARAMEDICS WERE CALLED 3 MINUTES AFTER TESTING THE PRODIGY METER AND ARRIVED IN 3 MINUTES. UPON ARRIVAL THE PARAMEDICS TESTED THE END-USER'S BLOOD GLUCOSE WITH THEIR METER AND RECEIVED A 26MG/DL. REPORTER STATED THE PARAMEDICS GAVE AN INJECTION AND ALSO GAVE FLUID THROUGH AN IV. REPORTER IS NOT SURE WHAT MEDICATION OR FLUIDS WERE PROVIDED TO END-USER. PARAMEDICS RETESTED PRIOR TO LEAVING THE END-USER AND THE END-USER'S BLOOD GLUCOSE WAS 180 MG/DL. NO FURTHER INFORMATION WAS PROVIDED REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655816 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D170609-2 00384840518858

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Life Threatening| R ASPIRIN| FLOMAX| LEVEMIR 20 UNITS BID| LYRICA| METFORMIN| METOPROLOL| NOVOLOG 10 UNITS TID