BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6970906 · Received October 24, 2017

    Report

    Report Number
    3005862821-2017-00105
    Event Type
    Injury
    Date Received
    October 24, 2017
    Date of Event
    September 15, 2017
    Report Date
    September 20, 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
    CA, 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 1.0¿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 RETURNED STRIPS (STRIP LOT NUMBER:D160322-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 55/58 MG/DL, FOR LEVEL HIGH WERE 247/248 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 RETAIN STRIPS TEST OF SAME BATCH FROM OUR WAREHOUSE (STRIP LOT NUMBER:D160322-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 53/55 MG/DL; FOR LEVEL HIGH WERE 240/238 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.

    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 NOV. 02, 2016. THE STRIP LOT # D160322-1 WAS MANUFACTURED ON 03/22/2016 AND EXPIRED IN 03/2018. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS . OK BIOTECH TESTED THE RETAIN STRIPS OF LOT#D160322-1 WITH IN HOUSE METER AND CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 63/59 MG/DL; FOR LEVEL HIGH WERE 216/228 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 3005862821-2017-00105 TO SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICES. DEVICES WERE RETURNED FROM (B)(6) ON OCT. 24,2017 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 515 PM AFTER THE END USER RECEIVED INCONSISTENT RESULTS FROM HER TWO PRODIGY DIABETES METERS. THE END USER PERFORMED TWO BLOOD GLUCOSE TEST ON 2 SEPARATE PRODIGY METERS AND RECEIVED READINGS OF 500 MG/DL AND 275 MG/DL. OUT OF CONCERN FOR THE HIGH READING OVER 500 MG/DL THE END USER SOUGHT MEDICAL ATTENTION. THE END USER REFUSED TO PROVIDE ANY OF THE PERTINENT INFORMATION ON THE INITIAL CALL. SO SEVERAL ATTEMPTS WERE MADE TO CONTACT THE END USER TO OBTAIN ADDITIONAL INFORMATION IN REGARDS TO THIS MEDICAL ATTENTION. ALL ATTEMPTS WERE UNSUCCESSFUL, SO THEREFORE NO FURTHER DETAILS COULD BE GATHERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753336 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800 - D160322-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention