BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 8810528 · Received July 22, 2019

    Report

    Report Number
    3005862821-2019-00029
    Event Type
    Injury
    Date Received
    July 22, 2019
    Date of Event
    June 12, 2019
    Report Date
    June 19, 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 · 0

    SUSPECTED DEVICE RETURNED TO OK BIOTECH ON (B)(6) 2019. THE METER SERIAL # REVISED TO 51850-3216602 (INITIAL SUBMISSION WAS #51850-3215602) WE EVALUATED THE RETURNED METER AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. 1. WE TESTED THE STANDBY CURRENT OF RETURNED METER, THE RESULT WAS 1.0¿A. THE CRITERIA IS <55 A. PASS. 2. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. 3. WE TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND RETURNED STRIPS (STRIP LOT NUMBER: D170427-1, ONLY 5 PCS ). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 235/215 MG/DL, FOR LEVEL HIGH WERE 357/532 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~85 MG/DL; LEVEL HIGH 210~320 MG/DL. ALL RESULTS WERE OUT OF THE ACCEPTANCE RANGE. DESICCANT INSIDE THE STRIP BOTTLE HAD COLOR CHANGED. 4. WE TESTED THE RETAIN STRIPS FROM OUR WAREHOUSE (STRIP LOT NUMBER:D170427-1 ). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 70/66 MG/DL; FOR LEVEL HIGH WERE 256/262 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~85 MG/DL; LEVEL HIGH 210~320 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS . PATIENT USED EXPIRED STRIPS TO TEST BLOOD WHICH MIGHT CAUSED OR CONTRIBUTED TO ERROR READINGS. USER STORAGE OR OPERATION ISSUE.

    Description of Event or Problem · 0

    THIS IS A SUPPLEMENTAL REPORT TO INITIAL REPORT 3005862821-2019-00029 TO SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICES. DEVICES WERE RETURNED FROM PRODIGY DIABETES CARE ON (B)(6), 2019 AND AN INVESTIGATION RESULTS OF THE SUSPECT DEVICES WERE COMPLETED BY OK BIOTECH.

    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 12/29/2016. THE STRIP LOT # D170427-1 WAS MANUFACTURED ON 04/27/2017 AND EXPIRED IN 04/27/2019. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS. BECAUSE PATIENT USED EXPIRED STRIPS TO TEST BLOOD WHICH MIGHT CAUSED OR CONTRIBUTED TO ERROR READINGS. USER STORAGE OR OPERATION ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AT THE END-USER'S THERAPY SESSION. THE END-USER STATED THAT HE TOOK A BLOOD GLUCOSE TEST AT 7:15AM AND RECEIVED A RESULT OF 196MG/DL. HE THEN LEFT HOME TO GO TO HIS THERAPY SESSION. HE THEN PASSED OUT AT THERAPY AND THE EMS WAS CALLED. WHEN PARAMEDICS ARRIVED, THEY TOOK HIS BLOOD GLUCOSE AND RECEIVED A RESULT OF 31MG/DL. PARAMEDICS GAVE THE END-USER A GLUCOSE IV AND A GLUCOSE SOLUTION OVER HIS GUMS. HE REFUSED TO GO TO THE ER. BEFORE LEAVING PARAMEDICS CHECKED HIS BLOOD GLUCOSE AND GOT A RESULT 145MG/DL. THERE WAS ABOUT 2 HOURS BETWEEN TESTING WITH THE PRODIGY METER AND THE PARAMEDICS METER. THE END-USER TESTS 3 TIMES A DAY AND HAS BEEN USING THE PRODIGY METER FOR ABOUT 2 YEARS. HE WAS USING EXPIRED TEST STRIPS, HE WAS EDUCATED NOT TO USE PRODUCTS PAST THE EXPIRATION DATE OR 90 DAYS FROM OPENING WHICHEVER COMES 1ST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604847 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D170427-1 00384840518858

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening LEVEMIR| LISINOPRIL| LEVEMIR| LISINOPRIL