BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 7036258 · Received November 16, 2017

    Report

    Report Number
    3005862821-2017-00123
    Event Type
    Injury
    Date Received
    November 16, 2017
    Date of Event
    October 16, 2017
    Report Date
    October 16, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841518505
    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. OKB TESTED THE STANDBY CURRENT OF RETURNED METER, THE RESULT WAS 1.6A. THE CRITERIA IS <55A. 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:D160316-1 ). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 53/52 MG/DL, FOR LEVEL HIGH WERE 265/264 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~80 MG/DL; LEVEL HIGH 210~310 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS . WE TESTED THE RETAIN STRIPS FROM OUR WAREHOUSE (SAME AS PATIENT'S STRIP LOT NUMBER:D160316-1 ). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 50/50 MG/DL; FOR LEVEL HIGH WERE 271/261 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~80 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)(6) ON 10/31/2012. THE STRIP LOT # D160316-1 WAS MANUFACTURED ON 03/16/2016 AND EXPIRED IN MARCH 2018.OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS . OKB TESTED THE RETAIN STRIPS OF SAME BATCH FROM OUR WAREHOUSE. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 58/51 MG/DL; FOR LEVEL HIGH WERE 245/251 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~80 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 3005862821-2017-00123 TO SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICES. DEVICES WERE RETURNED FROM PRODIGY DIABETES CARE ON NOV. 16, 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 AM AFTER THE END USER RECEIVED HIGHER THAN NORMAL BLOOD GLUCOSE RESULTS FROM HER PRODIGY DIABETES METER. THE END USER WAS UNRESPONSIVE WITH A BLOOD GLUCOSE READING OF 268 MG/DL. THE PARAMEDICS WERE CALLED AND UPON ARRIVAL THEY PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND THE RESULT WAS 42 MG/DL. THE END USER WAS GIVEN AN IV FLUID TO ASSIST IN STABILIZING HER BLOOD GLUCOSE LEVEL ALONG WITH A PEANUT BUTTER AND JELLY SANDWICH. SUBSEQUENTLY IT WAS DETERMINED THAT TRANSPORT TO THE ER WAS NOT NECESSARY. NO ADDITIONAL DETAILS WERE PROVIDED IN REGARDS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816917 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 54800-D160316-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention ASPIRIN 81 MG| CALCIUM ACETATE| CARVEDILOL| GABAPENTIN| KEPPRA| NEXUIM| PRAVASTATIN| RENAL VITAMINS