BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6401705 · Received March 14, 2017

    Report

    Report Number
    3005862821-2017-00024
    Event Type
    Injury
    Date Received
    March 14, 2017
    Date of Event
    February 10, 2017
    Report Date
    February 10, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 TEST WAS 1.3¿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:D150904-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 63/65 MG/DL, FOR LEVEL HIGH WERE 286/287 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 25~70 MG/DL; LEVEL HIGH 210~310 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS. WE TESTED THE RETAIN STRIPS (STRIP LOT NUMBER SAME AS RETURNED STRIPS:D150904-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 63/62 MG/DL; FOR LEVEL HIGH WERE 260/268 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 25~70 MG/DL; LEVEL HIGH 210~310 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 (B)(4) ON 11/06/2015. THE STRIP LOT #D150904-1 WAS MANUFACTURED ON 09/04/2015 AND EXPIRED IN 09/2017. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS . WE TESTED THE RETAIN STRIPS OF LOT #D150904-1, THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 63/62 MG/DL; FOR LEVEL HIGH WERE 260/268 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 25~70 MG/DL; LEVEL HIGH 210~310 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 3005862821-2017-00024 TO SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICES. DEVICES WERE RETURNED FROM (B)(4) ON 03/14//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 3:00AM AFTER THE END USER RECEIVED A GLUCOSE READING OF 438 MG/DL FROM THE PRODIGY DIABETES GLUCOSE METER. THERE WERE NO SYMPTOMS ASSOCIATED WITH THE MEDICAL EVENT BUT THE PARAMEDICS WERE CALLED DUE TO THE HIGH READING. THE PARAMEDICS PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER WITH A RESULT OF 211 MG/DL AND ADMINISTERED IV FLUIDS. THE END USER WAS TRANSPORTED TO THE ER AND UPON ARRIVAL HER BLOOD GLUCOSE WAS 143 MG/DL. ADDITIONAL IV FLUIDS WERE ADMINISTERED AND AFTER SEVERAL HOURS IN THE ER THE END USER WAS DISCHARGED AND INSTRUCTED TO FOLLOW-UP WITH HER PCP. NO ADDITIONAL INFORMATION WAS PROVIDED IN RELATIONS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185758 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800 - D150904-1

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention CLONAZEPAM 1MG 1/2 TAB AM AND 1 TAB PM| DUREZOL 0.05% 1 DROP EVERY EVENING| FLOMAX 0.4 MG ONCE DAILY| METFORMIN 500MG ONE TAB AM AND ONE TAB PM| PANTOPRAZOLE 20 MG 1 TAB DAILY| SERTRALINE HCL (ZOLOFT) 25MG 1 TAB ONCE DAILY