BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6438376 · Received March 28, 2017

    Report

    Report Number
    3005862821-2017-00031
    Event Type
    Injury
    Date Received
    March 28, 2017
    Date of Event
    February 25, 2017
    Report Date
    February 25, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 PDC ON 06/29/2012. THE STRIP LOT #D151202-1 WAS MANUFACTURED ON 12/02/2015 AND EXPIRED IN 12/2017. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS. WE TESTED THE RETAIN STRIPS OF SAME LOT#D151202-1, THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 50/53 MG/DL; FOR LEVEL HIGH WERE 237/228 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

    WE TESTED THE STANDBY CURRENT ON THE RETURNED METER, THE RESULT WAS 1.3¿A. THE CRITERIA IS <55¿A. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION OF RETURNED METER WERE OK. WE TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND RETURNED STRIPS (STRIP LOT NUMBER:D151202-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 86/75 MG/DL, FOR LEVEL HIGH WERE 288/290 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 25~70 MG/DL; LEVEL HIGH 210~310 MG/DL. TWO RESULTS WERE OUT OF THE ACCEPTANCE RANGE. NG. WE TESTED THE RETAIN STRIPS (SAME STRIP LOT NUMBER:D151202-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 59/55 MG/DL; FOR LEVEL HIGH WERE 250/252 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. ACCORDING TO ABOVE, WE FOUND THE STRIPS RETURNED STRIPS WERE MOIST. AND RESULTS OF INCORRECT READINGS MIGHT BECAUSE PATIENT STORED THE STRIPS IN A UNCONTROLLED OR IMPROPER ENVIRONMENT AND LEAD TO STRIPS MOIST AND PRODUCED INCORRECT READINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE END USER SOUGHT MEDICAL ATTENTION ON (B)(6) 2017 AT 7:00 PM AFTER RECEIVING HIGH BLOOD GLUCOSE READINGS FROM HIS PRODIGY DIABETES GLUCOSE METER. THE END USER WAS FEELING WEAK AND DROWSY AND VISITED THE ER. THE CALLER REFUSED TO PROVIDE ANY FURTHER PERTINENT INFORMATION IN REGARDS TO THIS MEDICAL EVENT.

    Description of Event or Problem · 1

    THIS IS A SUPPLEMENTAL REPORT TO INITIAL REPORT 3005862821-2017-00031 TO SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICES. DEVICES WERE RETURNED FROM (B)(4) ON 03/30/2017 AND AN INVESTIGATION RESULTS OF THE SUSPECT DEVICES WERE COMPLETED BY OK BIOTECH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223544 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800-D151202-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention METFORMIN