BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 9254062 · Received October 29, 2019

    Report

    Report Number
    3005862821-2019-00059
    Event Type
    Injury
    Date Received
    October 29, 2019
    Date of Event
    September 25, 2019
    Report Date
    October 2, 2019
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841518505
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 1.1?A. THE CRITERIA IS <55?A. 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:D181002-1 ). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 213/293 MG/DL, FOR LEVEL HIGH WERE 452/433 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~80 MG/DL; LEVEL HIGH 210~320 MG/DL. ALL RESULTS WERE OUT OF THE ACCEPTANCE RANGE. AND WE FOUND THE DESICCANT INSIDE THE STRIP BOTTLE HAD COLOR CHANGED. 4. WE TESTED THE RETAIN STRIPS FROM OUR WAREHOUSE (SAME AS PATIENT'S BACTH, STRIP LOT NUMBER:D181002-1 ). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 56/60 MG/DL; FOR LEVEL HIGH WERE 241/251 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~80 MG/DL; LEVEL HIGH 210~320 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS. BECAUSE THE DESICCANT COLOR CHANGED FROM PATIENT'S STRIPS, INDICATE THE STRIPS MIGHT GET MOISTURE. PATIENT USED THOSE STRIPS TO TEST BLOOD MIGHT CAUSED OR CONTRIBUTED TO HIGHER READINGS. USER STORAGE OR OPERATION ISSUE.

    Description of Event or Problem · 0

    THIS IS A SUPPLEMENTAL REPORT TO SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICES. DEVICES WERE RETURNED FROM PRODIGY DIABETES CARE ON DECEMBER 06, 2019 AND AN INVESTIGATION RESULTS OF THE SUSPECT DEVICES WERE COMPLETED BY OK BIOTECH.

    Additional Manufacturer Narrative · 1

    BECAUSE DEVICE WAS NOT RETURNED TO OK BIOTECH, THEREFORE, WE WERE UNABLE TO PERFORM FURTHER TESTING ON THE SUSPECTED DEVICE. 1. 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 (B)(6) 2017. 2. THE STRIP LOT # D181002-1 WAS MANUFACTURED ON 10/02/2018 AND EXPIRED IN 10/02/2020. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS . 3. WE TESTED THE RETAIN STRIPS OF SAME BATCH (LOT# S181002-1) FROM OUR WAREHOUSE. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 58/56 MG/DL; FOR LEVEL HIGH WERE 246/240 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~80 MG/DL; LEVEL HIGH 210~320 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

    END-USER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AROUND 3:00AM AT HIS HOME. END-USER STATED THAT HE TESTED HIS BLOOD GLUCOSE AND RECEIVED A RESULT OF 360MG/DL WHICH PROMPTED HIM TO TAKE 8UNITS OF INSULIN. HE STATED HE FELT CONFUSED AND CALLED HIS DAUGHTER WHO THEN CAME AND DROVE HIM TO THE HOSPITAL. THE END-USER STATED THAT HIS BLOOD GLUCOSE WAS 60MGDL UPON ARRIVING AT THE HOSPITAL. HE STATED THAT HE WAS GIVEN ORANGE JUICE TO RAISE HIS BLOOD GLUCOSE. HE WAS NOT TREATED FOR ANYTHING ELSE AND WAS NOT ADMITTED. HE WAS AT (B)(6) HOSPITAL LOCATED AT (B)(6) FOR ABOUT 30 MINUTES. HE STATED HIS BLOOD GLUCOSE WAS 106 MG/DL WHEN HE WAS DISCHARGED FROM THE HOSPITAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1047889 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D181002-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization ATORVASTATIN| LISINOPRIL| UNKNOWN INSULIN