BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6309848 · Received February 7, 2017

    Report

    Report Number
    3005862821-2017-00013
    Event Type
    Injury
    Date Received
    February 7, 2017
    Date of Event
    January 3, 2017
    Report Date
    January 3, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE AND STRIPS EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER AND STRIPS WERE ALL OPERATED WITHIN SPECIFICATIONS. WE TESTED THE STANDBY CURRENT OF RETURNED METER, THE RESULT WAS 1.2¿A. THE CRITERIA IS <55¿A. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION WERE OK. WE TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND RETURNED STRIPS (STRIP LOT NUMBER:D160119-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 53/55 MG/DL, FOR LEVEL HIGH WERE 263/262 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 25~70 MG/DL; LEVEL HIGH 210~310 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS. WE TESTED THE RETAIN STRIPS (SAME STRIP LOT AS PATIENT'S STRIP, LOT#D160119-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 54/52 MG/DL; FOR LEVEL HIGH WERE 271/279 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 25~70 MG/DL; LEVEL HIGH 210~310 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS. THERE IS NO QUALITY DIFFERENCE ON PATIENT'S STRIPS AND THE RETAIN STRIP IN OUR WAREHOUSE.

    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 (B)(4) ON 10/28/2016. THE STRIP LOT #D160119-1 WAS MANUFACTURED ON 01/19/2016 AND WILL BE EXPIRED IN JAN 19, 2018. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS . WE TESTED THE RETAIN STRIPS OF LOT#D160119-1. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 54/52 MG/DL; FOR LEVEL HIGH WERE 271/279 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 25~70 MG/DL; LEVEL HIGH 210~310 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

    THIS IS A SUPPLEMENTAL REPORT TO INITIAL REPORT 3005862821-2017-00013 TO SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICES. DEVICES WERE RETURNED FROM PRODIGY DIABETES CARE ON 02/14/2017 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 ON (B)(6) 2016 AT 9:00 PM DUE TO THE END USER RECEIVING BLOOD GLUCOSE RESULTS IN THE 70'S ACCOMPANIED WITH SYMPTOMS OF LOW BLOOD LEVELS. THE END USER WAS LETHARGIC, CONFUSED AND NOT FEELING WELL. THE PARAMEDICS WERE CALLED AND THEY PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND THE RESULT WAS 78 MG/DL. THEY ADMINISTERED AN IV OF GLUCOSE AND TRANSPORTED THE END USER TO THE ER. UPON ARRIVAL TO THE ER HER BLOOD GLUCOSE WAS IN THE 60'S. THE END USER WAS ADMITTED TO THE HOSPITAL FROM (B)(6) 2016 FOR AN ISSUE THAT WAS UNRELATED TO HER DIABETES. UPON DISCHARGE THE END USER WAS INSTRUCTED TO FOLLOW UP WITH HER PCP. NO ADDITIONAL INFORMATION WAS PROVIDED IN REGARDS TO THE MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91624 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 54800-D160119-1

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R GLIPIZIDE 10MG TWICE DAILY| PIOGLITAZONE 45MG ONCE DAILY IN THE MORNING| TRAJENTA 5MG 1 TABLET DAILY