BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6272048 · Received January 23, 2017

    Report

    Report Number
    3005862821-2017-00011
    Event Type
    Injury
    Date Received
    January 23, 2017
    Date of Event
    December 27, 2016
    Report Date
    December 27, 2016
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 (B)(4) ON 01/24/2014. THE STRIP LOT #D6160225-1 WAS MANUFACTURED ON 02/25/2016 AND EXPIRED IN 02/2018. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS . WE TESTED THE RETAIN STRIPS OF THE LOT #D6160225-1 . THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 50/53 MG/DL; FOR LEVEL HIGH WERE 248/234 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.

    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 1.0¿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 IN HOUSE STRIPS (STRIPS LOT# D160526-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 61/56 MG/DL, FOR LEVEL HIGH WERE 243/238 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. BECASUE PATIENT DID NOT RETURN HER STRIPS, WE TESTED THE SUSPECTED METER WITH RETAIN STRIPS(SAME STRIP LOT NUMBER AS PATIENT'S REPORTING STRIP, LOT#D6160225-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 50/53 MG/DL, FOR LEVEL HIGH WERE 248/234 MG/DL. THE CONTROL SOLUTION RANGES ARE: LEVEL LOW 25~70 MG/DL; LEVEL HIGH 210~310 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE END USER SOUGHT MEDICAL ATTENTION ON (B)(6) 2016 AT 2:00 PM AFTER RECEIVING A READING IN THE 500 MG/DL FROM THE PRODIGY DIABETES GLUCOSE METER. THE END USER COULD NOT TALK OR STAND; THEREFORE, THE PARAMEDICS WERE CALLED. THE PARAMEDICS PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER BUT SHE COULD NOT RECALL WHAT THE ACTUAL RESULT WAS. THE PARAMEDICS ADMINISTERED IV FLUID TO ASSIST WITH STABILIZING HER BLOOD GLUCOSE LEVELS. NO FURTHER DETAILS WERE PROVIDED IN REGARDS TO THE MEDICAL EVENT.

    Description of Event or Problem · 1

    THIS IS A SUPPLEMENTAL REPORT TO INITIAL REPORT 3005862821-2017-00011 TO SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICES. DEVICES WERE RETURNED FROM PRODIGY DIABETES CARE ON 02/14//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
    52250 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 72500-D6160225-1

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention LANTUS 17 UNITS| LANTUS 4 UNITS LUNCH| LANTUS 5 UNITS DINNER