BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6536062 · Received May 2, 2017

    Report

    Report Number
    3005862821-2017-00035
    Event Type
    Injury
    Date Received
    May 2, 2017
    Date of Event
    March 29, 2017
    Report Date
    March 29, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    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 05/24/2013. THE STRIP LOT #D160503-1 WAS MANUFACTURED ON 05/03/2016 AND EXPIRED IN 05/2018. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS. WE TESTED THE RETAIN STRIPS OF LOT #D160503-1, THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 54/56 MG/DL; FOR LEVEL HIGH WERE 228/227 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.

    Additional Manufacturer Narrative · 1

    SUSPECTED METER AND STRIPS WERE RETURNED AND EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER AND STRIPS WERE OPERATED WITHIN SPECIFICATIONS. WE TESTED THE STANDBY CURRENT OF THE METER, THE RESULT WAS 1.2¿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:D160503-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 58/55 MG/DL, FOR LEVEL HIGH WERE 233/236 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 RETAIN STRIPS FROM OUR WAREHOUSE (SAME STRIP LOT AS RETURNED STRIP, LOT#:D160503-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 63/55 MG/DL; FOR LEVEL HIGH WERE 239/233 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE END USER INITIALLY SOUGHT MEDICAL ATTENTION ON (B)(6) 2017 AT 4:00 PM FOR BLOOD PRESSURE RELATED ISSUES. THE END USER WAS UNABLE TO WALK, BREATHE OR STAND. DURING THE TIME OF THE MEDICAL EVENT HER BLOOD GLUCOSE READING WAS 276 MG/DL. SHE ORIGINALLY VISITED THE ER BECAUSE SHE FELT HER BLOOD PRESSURE WAS TOO LOW DUE TO CONSUMING MORE THAN THE REQUIRED DOSAGE OF MEDICATION. UPON ARRIVAL AT THE ER HER BLOOD GLUCOSE READING WAS 476 MG/DL. NO INFORMATION WAS PROVIDED IN REGARDS TO TREATMENT PROVIDED WITH STABILIZING HER BLOOD GLUCOSE. THE END USER WAS DISCHARGED AFTER 3 DAYS IN THE HOSPITAL AND WAS INSTRUCTED TO FOLLOW-UP WITH HER PCP AND CONTINUE TAKING HER INSULIN AS PRESCRIBED. NO FURTHER DETAILS WERE PROVIDED.

    Description of Event or Problem · 1

    THIS IS A SUPPLEMENTAL REPORT TO INITIAL REPORT 3005862821-2017-00035 TO SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICES. DEVICES WERE RETURNED FROM PRODIGY DIABETES CARE ON 05/03//2017 AND AN INVESTIGATION RESULTS OF THE SUSPECT DEVICES WERE COMPLETED BY OK BIOTECH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318223 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800-D160503-1

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R BABY ASPIRIN 2X 81 MG AM| HUMALOG 10 UNITS IN AM| HUMALOG 5 UNITS PM| HUMULIN N 18 UNITS AM| MIDODRINE 5MG| OMEPRAZOLE 20MG TWICE A DAY| SIMVASTATIN 20MG