BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6826294 · Received August 29, 2017

    Report

    Report Number
    3005862821-2017-00084
    Event Type
    Injury
    Date Received
    August 29, 2017
    Date of Event
    July 21, 2017
    Report Date
    July 28, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 1.8 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:D160729-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 60/56 MG/DL, FOR LEVEL HIGH WERE 229/230 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 SUSPECTED METER WITH RETAIN STRIPS FROM OUR WAREHOUSE (SAME STRIP LOT AS PATIENT'S STRIP: D160729-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 61/67 MG/DL; FOR LEVEL HIGH WERE 256/245 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 (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 # D160729-1 WAS MANUFACTURED ON 07/29/2016 AND EXPIRED IN 07/2018. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS . WE TESTED THE RETAIN STRIPS OF SAME BATCH FROM OUR WAREHOUSE. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 63/64 MG/DL; FOR LEVEL HIGH WERE 224/242 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 . 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 3005862821-2017-00084 TO SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICES. DEVICES WERE RETURNED FROM PRODIGY DIABETES CARE ON SEP. 04,2017 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 4:00 PM AFTER THE END USER RECEIVED HIGHER THAN NORMAL BLOOD GLUCOSE RESULTS FROM HER PRODIGY DIABETES METER. THE END USER WAS SWEATING AND NON-RESPONSIVE ACCOMPANIED WITH A BLOOD GLUCOSE READING OF 337 MG/DL. ADDITIONAL BLOOD GLUCOSE TESTS WERE PERFORMED WITH RESULTS RANGING FROM 213 MG/DL - 341 MG/DL. THE END USER WAS TAKEN TO THE ER AND UPON ARRIVAL HER BLOOD GLUCOSE WAS 44 MG/DL. SHE WAS GIVEN 2 HAM SANDWICHES AND ORANGE JUICE. AFTER 7 HOURS AT THE ER THE END USER WAS DISCHARGED WITH A BLOOD GLUCOSE READING OF 128 MG/DL. SHE WAS INSTRUCTED TO FOLLOW-UP WITH HER PCP. NO ADDITIONAL DETAILS WERE PROVIDED IN REGARDS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608671 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800 - D160729-1

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention ASPIRIN 81 MG| COQ10 100MG| CYCLOBENZAPRINE 5MG TABLET ONCE| ESOMEPRAZOLE 40MG DAILY| FUROSEMIDE 40 MG DAILY| IMITREX 100MG| LANTUS 16 UNITS AT NIGHT| LORATADINE 10MG DAILY| METFORMIN 500MG| METOPROLOL 100MG AS NEEDED| NOVOLOG 22 UNITS 3 TIMES A DAY| POTASSIUM 10 MG 1 DAILY| QUINAPRIL 20-25MG| SIMVASTATIN 40MG IN THE EVENING| TOPAMAX 25MG| TOVIAZ 8 MG ONCE DAILY| VALACYCLOVIR 500 MG ONCE DAILY| VICTOZA 18 MG ONCE DAILY| VITAMIN D3 1000 ONE DAILY| ZOFRAN 4 MG