BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 8863536 · Received August 6, 2019

    Report

    Report Number
    3005862821-2019-00033
    Event Type
    Injury
    Date Received
    August 6, 2019
    Date of Event
    June 30, 2019
    Report Date
    July 11, 2019
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384840518858
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. WE TESTED THE STANDBY CURRENT OF RETURNED MERER, THE RESULT WAS 0.9UA. THE CRITERIA IS <55UA. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. WE TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND RETURNED STRIPS (STRIP LOT NUMBER: D170828-1, ONLY 5 PCS). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 63/63 MG/DL, FOR LEVEL HIGH WERE 249/251 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 ACCEPTABLE RANGE. PASS. HOWEVER WE FOUND THE DESICCANT INSIDE THE STRIP BOTTLE HAD COLOR CHANGED. WE TESTED THE RETAIN STRIPS FROM OUR WAREHOUSE (STRIP LOT NUMBER: D170828-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 64/65 MG/DL; FOR LEVEL HIGH WERE 250/259 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. BECAUSE THE DESICCANT COLOR CHANGED FROM PATIENT'S STRIPS, INDICATE THE STRIPS MIGHT GET MOISTURE. PATIENT USED THOSE STRIPS TO TEST BLOOD MIGHT CAUSED OR CONTRIBUTED TO HIGHER READINGS. USER STORAGE OR OPERATION ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AROUND 8:30PM. THE CALLER STATED THAT THE END-USER RECEIVED A READING OF 66MG/DL. END-USER THEN TOOK HER INSULIN BASED OFF THE RESULT SHE RECEIVED WHICH LED TO THE END-USER BEING FOUND UNRESPONSIVE. PARAMEDICS WERE CALLED AROUND 10 MINUTES AFTER TESTING WITH HER PRODIGY METER. PARAMEDICS ARRIVED WITHIN 10-15MINUTES AND TESTED HER BLOOD GLUCOSE WITH THEIR METER AND RECEIVED A RESULT OF 34MG/DL. THERE WAS ABOUT 20 MINUTES BETWEEN TESTING WITH THE PRODIGY METER AND THE PARAMEDICS METER. THERE WAS NO FOOD DRINK OR MEDICATIONS TAKEN WHILE WAITING FOR THE PARAMEDICS. THE END-USER WAS GIVEN 2 GLUCOSE IV SOLUTIONS AND WAS NOT TRANSPORTED TO THE HOSPITAL. THE END-USER TAKES THE FOLLOWING INSULIN LANTUS 25 UNITS AT NOON, NOVOLOG 2-10 UNITS WHEN SHE EATS, NOVOLOG 20 UNITS WHEN RESULT IS OVER 400MG/DL. NO ADDITIONAL DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659874 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D170828-1 00384840518858

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention