BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6676222 · Received June 29, 2017

    Report

    Report Number
    3005862821-2017-00057
    Event Type
    Injury
    Date Received
    June 29, 2017
    Date of Event
    January 31, 2017
    Report Date
    May 31, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER CAREGIVERS

    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 METER, THE RESULT WAS 1.5 A. THE CRITERIA IS <55 A. 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: D160811-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 59/56 MG/DL, FOR LEVEL HIGH WERE 253/261 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 TESTED THE SUSPECTED METER WITH RETAIN STRIPS (SAME BATCH AS PATIENT'S STRIPS, LOT NUMBER: D160811-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 69/64 MG/DL; FOR LEVEL HIGH WERE 264/268 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.

    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 06/07/2016. THE STRIP LOT # D160811-1 WAS MANUFACTURED ON 08/11/2016 AND EXPIRED IN 08/2018. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS . WE TESTED THE RETAIN STRIPS(SAME BATCH AS PATIENT'S STRIPS) FROM WAREHOUSE. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 67/67 MG/DL; FOR LEVEL HIGH WERE 264/261 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

    DEVICES WERE RETURNED FROM PRODIGY DIABETES CARE ON 06/29/2017 AND AN INVESTIGATION RESULTS OF THE SUSPECT DEVICES WERE COMPLETED BY OK BIOTECH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT IN (B)(6) 2017 AFTER THE END USER WAS RECEIVING INCONSISTENT HIGH AND LOW READINGS FROM HER PRODIGY DIABETES METER. THE END USER WAS CLAMMY AND HER BLOOD GLUCOSE READING AT THE TIME OF THE MEDICAL EVENT WAS 40 MG/DL. THE PARAMEDICS WERE CALLED AND THE END USER WAS TAKEN TO THE ER. AFTER A FEW HOURS, THE END USER WAS DISCHARGED AND WAS INSTRUCTED TO MONITOR HER BLOOD GLUCOSE AND FOLLOW-UP WITH HER PCP. THE END USER WAS NOT ABLE TO RECALL ANY FURTHER DETAILS IN REGARDS TO SERVICES RENDERED FROM THE PARAMEDICS OR WHILE SHE WAS AT THE ER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458661 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800-D160811-1

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention CITALOPRAM 20 MG ONE TABLET ONCE A DAY| COUMADIN 3 MG ONCE A DAY| HUMALOG| LANTUS 42 UNITS IN THE MORNING EVERYDAY| LISINOPRIL 10 MG 1 TABLET ONCE A DAY| LLIVOTHYROXIN .075 MG 1 TABLET ONCE A DAY| LOSARTAN HTC 100MG/12.5MG 1 TABLET ONCE A DAY| NIACIN 500 MG 1 TABLET ONCE A DAY| SIMVASTATIN 20MG 1/2 EVERY OTHER NIGHT