BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6766343 · Received August 4, 2017

    Report

    Report Number
    3005862821-2017-00075
    Event Type
    Injury
    Date Received
    August 4, 2017
    Date of Event
    June 25, 2017
    Report Date
    July 6, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. 1. WE TESTED THE STANDBY CURRENT OF RETURNED METER, THE RESULT WAS 3.4 A. THE CRITERIA IS <55A. PASS. 2. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. 3. WE TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND RETURNED STRIPS (STRIP LOT NUMBER:D161020-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 54/56 MG/DL, FOR LEVEL HIGH WERE 252/251 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 . 4.WE TESTED THE RETAIN STRIPS OF SAME BACTH (STRIP LOT NUMBER:D161020-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 61/56 MG/DL; FOR LEVEL HIGH WERE 232/237 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 (B)(4) ON 02/23/2017. THE STRIP LOT # D161020-1 WAS MANUFACTURED ON 10/20/2016 AND EXPIRED IN 10/2018. 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 61/56 MG/DL; FOR LEVEL HIGH WERE 232/237 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 3005862821-2017-00075 TO SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICES. DEVICES WERE RETURNED FROM PRODIGY DIABETES CARE ON AUG 23,2017 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 12:00PM AFTER THE END USER WAS RECEIVING HIGHER THAN NORMAL BLOOD GLUCOSE RESULTS FROM HIS PRODIGY DIABETES METER. THE END USER PERFORMED SEVERAL BLOOD GLUCOSE TESTS AND RECEIVED THE FOLLOWING RESULTS - 575 MG/DL, 585 MG/DL AND 595 MG/DL. BASED ON THE HIGH READINGS AND FEELING TIRED THE END USER WAS TAKEN TO THE ER.. UPON ARRIVAL TO THE ER THE END USER'S BLOOD GLUCOSE WAS 200 MG/DL. AN UNKNOWN IV FLUID WAS ADMINISTERED ALONG WITH A SHOT OF HUMALOG. AFTER 3 DAYS IN THE HOSPITAL THE END USER WAS DISCHARGED AND INSTRUCTED TO MONITOR HIS BLOOD GLUCOSE LEVELS. NO ADDITIONAL DETAILS WERE PROVIDED IN RELATIONS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548007 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800 - D161020-1

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R ANTIDEPRESSANT - NAME UNKNOWN| LANTUS