BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 7062556 · Received November 28, 2017

    Report

    Report Number
    3005862821-2017-00128
    Event Type
    Injury
    Date Received
    November 28, 2017
    Date of Event
    October 27, 2017
    Report Date
    October 28, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841518505
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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 METER, THE RESULT WAS 1.1¿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 IN HOUSE STRIPS (STRIP LOT NUMBER: D160526-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 48/52 MG/DL, FOR LEVEL HIGH WERE 236/227 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW30~80 MG/DL; LEVEL HIGH 190~290 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS. WE TESTED THE RETAIN STRIPS (SAME STRIP BATCH AS PATIENT'S STRIP, LOT NUMBER:D160810-1) FROM OUR WAREHOUSE WITH RETURNED METER AND IN HOUSE CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 66/66 MG/DL; FOR LEVEL HIGH WERE 253/258 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. ACCORDING TO ABOVE TESTS, THE RETURNED METER WAS OPERATED WITHIN SPECIFICATION BUT RESULT OF INCORRECT READINGS MIGHT FROM PATIENT'S STRIP. BECAUSE THERE WAS ONLY 1 STRIP LEFT FROM PATIENT'S RETURN VIAL, AND THE DESICCANT COLOR IN THIS VIAL WAS TURNED TO PINK, WHICH INDICATE STRIP WAS MOIST. PATIENT MIGHT STORED THE STRIPS IN A UNCONTROLLED OR IMPROPER ENVIRONMENT AND LEAD TO STRIPS MOIST AND PRODUCED INCORRECT HIGH READINGS.

    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 (B)(4)), AND THE METER WAS QUALIFIED AND RELEASED BY THE QUALITY CONTROL DEPARTMENT AND SHIPPED TO PDC ON 02/23/2017. THE STRIP LOT # D160810-1 WAS MANUFACTURED ON AUGUST 10, 2016 AND EXPIRED IN AUGUST 2018. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS . ACCORDING TO PDC'S DESCRIPTION, THE STRIP WITH PATIENT MIGHT GET MOIST BECAUSE OF IMPROPER STORAGE AND EXPOSE THE TEST STRIPS TO ELEVATED HUMIDITY AND TEMPERATURE RANGES OUTSIDE THE REQUIRED STANDARDS. HENCE THE MOIST STRIP MIGHT PRODUCE INCORRECT HIGH READINGS.

    Description of Event or Problem · 1

    THIS IS A SUPPLEMENTAL REPORT TO INITIAL REPORT 3005862821-2017-00128 TO SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICES. DEVICES WERE RETURNED FROM (B)(6) ON DEC. 07, 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) 2017 AT 12:30 PM AFTER THE END USER RECEIVED HIGHER THAN NORMAL BLOOD GLUCOSE RESULTS FROM HIS PRODIGY DIABETES METER. IT WAS ALSO DISCOVERED THAT THE END USER WAS NOT HANDLING HIS TEST STRIPS PROPERLY BY ENSURING THAT THE VIAL IS CLOSED TIGHTLY AFTER EACH USE. THE DESICCANTS IN THE BOTTOM OF THE VIAL ARE RED WHICH COULD CONSTITUTE IMPROPER STORAGE AND EXPOSE THE TEST STRIPS TO ELEVATED HUMIDITY AND TEMPERATURE RANGES OUTSIDE THE REQUIRED STANDARDS. THE END USER EXPERIENCED CONFUSION, FATIGUE AND COULDN'T WALK ACCOMPANIED WITH A HIGH BLOOD GLUCOSE READING OF 428 MG/DL. AN ADDITIONAL BLOOD GLUCOSE TEST WAS PERFORMED 15 MINUTES LATER WITH A READING OF 293 MG/DL. THE END USER WAS TAKEN TO THE ER AND UPON ARRIVAL HIS BLOOD GLUCOSE READING WAS 128 MG/DL. DUE TO THE FACT THAT HIS BLOOD GLUCOSE WAS WITHIN NORMAL RANGE NO TREATMENT OR ADDITIONAL TESTING WAS NECESSARY. AFTER 2 HOURS IN THE ER THE END USER WAS DISCHARGED WITH A BLOOD GLUCOSE READING OF 128 MG/DL. NO ADDITIONAL DETAILS WERE PROVIDED IN REGARDS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844218 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800-D160810-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention METFORMIN