BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6438369 · Received March 28, 2017

    Report

    Report Number
    3005862821-2017-00028
    Event Type
    Injury
    Date Received
    March 28, 2017
    Date of Event
    February 21, 2017
    Report Date
    February 21, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 12/24/2015. THE STRIP LOT #D160608-2 WAS MANUFACTURED ON 06/08/2016 AND EXPIRED IN 06/2018. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS . WE TESTED THE RETAIN STRIPS OF SAME LOT #D160608-2, THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 58/63 MG/DL; FOR LEVEL HIGH WERE 255/260 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 DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. THE STANDBY CURRENT TEST OF THE RETURNED METER WAS 1.2¿A. THE CRITERIA IS <55¿A. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION OF THE RETURNED METER WERE 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 58/55 MG/DL, FOR LEVEL HIGH WERE 255/254 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. BECAUSE PATIENT DID NOT SEND BACK HIS STRIPS, WE TESTED THE RETURNED METER WITH RETAIN STRIPS IN OUR WAREHOUSE (SAME STRIP LOT AS PATIENT'S STRIP:D160608-2). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 58/63 MG/DL; FOR LEVEL HIGH WERE 255/260 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 MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2017 AT 7:30 PM AFTER THE END USER WAS RECEIVING INCONSISTENT HIGH BLOOD GLUCOSE READINGS FROM HER PRODIGY DIABETES METER. THE END USER RECEIVED TWO HIGH READINGS OF 520 MG/DL AND 270 MG/DL. AND DIDN'T FELT NAUSEOUS AND WENT TO THE ER. UPON ARRIVAL TO THE E.R., THE END USER'S BLOOD GLUCOSE WAS 234 MG/DL. NO ADDITIONAL TESTING OR MEDICATION WERE ADMINISTERED. AFTER BEING AT THE ER FOR LESS THAN AN HOUR THE END USER WAS DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED IN RELATIONS TO THIS MEDICAL EVENT.

    Description of Event or Problem · 1

    THIS IS A SUPPLEMENTAL REPORT TO INITIAL REPORT 3005862821-2017-00028 TO SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICES. DEVICES WERE RETURNED FROM (B)(4) ON 03/30//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
    223538 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800-D160608-2

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention A1 ASPIRIN| ALLOPURINOL| ARMOUR THYROID| B12| CARTIA DILTIAZEM| FOLIC ACID| GABAPENTIN| HUMULIN R 500| LANTUS| LEFLUNOMIDE| LISINOPRIL| METOPROLOL SUCCINATE ER| MINOXIDIL| NITROGLYCERIN| POTASSIUM CL| PREVACID