BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6816087 · Received August 24, 2017

    Report

    Report Number
    3005862821-2017-00080
    Event Type
    Injury
    Date Received
    August 24, 2017
    Date of Event
    July 11, 2017
    Report Date
    July 21, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 1.4 ¿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 IN HOUSE STRIPS (STRIP LOT NUMBER:D160526-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 50/52 MG/DL, FOR LEVEL HIGH WERE 224/225 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. BECAUSE PATIENT DID NOT RETURN HER STRIPS, SO WE TESTED THE RETAIN STRIPS IN OUR WAREHOUSE (SAME PATIENT'S STRIP LOT# D160727-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 63/67 MG/DL; FOR LEVEL HIGH WERE 248/242 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 11/24/2015. THE STRIP LOT # D160727-1 WAS MANUFACTURED ON 07/27/2016 AND EXPIRED IN 07/2018. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS . WE TESTED THE RETAIN STRIPS OF SAME PATIENT'S BATCH. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 65/66 MG/DL; FOR LEVEL HIGH WERE 268/251 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

    THIS IS A SUPPLEMENTAL REPORT TO INITIAL REPORT 3005862821-2017-00080 TO SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICES. DEVICES WERE RETURNED FROM (B)(6) ON SEP. 26,2017 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 10:00 AM AFTER RECEIVING HIGHER THAN NORMAL BLOOD GLUCOSE READINGS FROM HER PRODIGY DIABETES METER. THE END USER EXPERIENCED DIZZINESS ACCOMPANIED WITH HIGH BLOOD GLUCOSE READINGS OF 545 MG/DL AND 575 MG/DL. THE END USER WAS TAKEN TO THE ER AND UPON ARRIVAL HER BLOOD GLUCOSE WAS 283 MG/DL. THE CALLER STATED THAT NO TREATMENTS WERE ADMINISTERED AND THERE WAS NO ADDITIONAL TESTING AS WELL. AFTER 7 - 8 HOURS AT THE ER THE END USER WAS DISCHARGED WITH A BLOOD GLUCOSE READING OF 283 MG/DL. SHE WAS INSTRUCTED TO FOLLOW-UP WITH A CARDIOLOGIST. NO ADDITIONAL DETAILS WERE PROVIDED IN RELATIONS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598438 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800-D160727-1

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention AMLODIPINE BESYLATE , 5 MILLIGRAM 1 PILL A DAY| ASPIRIN , 81MG 1 PILL A DAY| DOCUSATE , 100MG TWICE DAILY AS NEEDED| ETHYLENE GLYCOL , 17MG 8 OZ DRINK ONCE A DAY| GLIPIZIDE , 10MG OR 1 PILL A DAY| LISINOPRIL 40MG 4 PILLS A DAY| METFORMIN HCL , 100MG 1 PILL A DAY| SANDOSTATIN , 20MG 1 PILL A DAY| SERTRALINE , 100MG 2 PILLS A DAY| VITAMIN D , 200UNIT 1 PILL A DAY