BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 7214556 · Received January 23, 2018

    Report

    Report Number
    3005862821-2018-00008
    Event Type
    Injury
    Date Received
    January 23, 2018
    Date of Event
    January 4, 2018
    Report Date
    January 5, 2018
    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 · 0

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. 1.OKB TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND RETURNED STRIPS (STRIP LOT NUMBER:D170608-2 ). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 58/51 MG/DL, FOR LEVEL HIGH WERE 243/234 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~85 MG/DL; LEVEL HIGH 210~320 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS . 2.WE TESTED THE RETAIN STRIPS TEST FROM OUR WAREHOUSE (SAME AS PATIENT STRIPS, LOT NUMBER:D170608-2 ) WITH RETURNED METER AND CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 55/50 MG/DL; FOR LEVEL HIGH WERE 243/240 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~85 MG/DL; LEVEL HIGH 210~320. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS . 3. WE TESTED THE RETURNED STRIPS WITH OUR IN HOUSE METER AND CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 60/55 MG/DL; FOR LEVEL HIGH WERE 252/247 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~85 MG/DL; LEVEL HIGH 210~320. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS.

    Description of Event or Problem · 0

    THIS IS A SUPPLEMENTAL REPORT TO INITIAL REPORT 3005862821-2018-00008 TO SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICES. DEVICES WERE RETURNED FROM PRODIGY DIABETES CARE ON JAN.30, 2018 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. ACCORDING TO PDC'S REPORT, THE METER SERIAL NO. (B)(4) WAS FOR THE SUSPECTED DEVICE, AND WE REVIEWED OUR MANUFACTURING RECORD BUT CAN'T FIND THIS METER SERIAL NO. IN OUR RECORD (DHR). PATIENT MIGHT GIVE INCORRECT SERIAL NUMBER TO US OR THIS METER WAS NOT MANUFACTURED BY US. THE STRIP LOT # D170608-2 WAS MANUFACTURED ON 06/08/2017 AND EXPIRED IN 06/08/2019. 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 65/64 MG/DL; FOR LEVEL HIGH WERE 260/265 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~85 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

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2018 AT 6:45 PM AFTER THE END USER RECEIVED HIGHER THAN NORMAL READINGS FROM HER PRODIGY DIABETES METER. THE END USER STATED SHE RECEIVED HIGH BLOOD GLUCOSE RESULTS OF 446 MG/DL AND 488 MG/DL ACCOMPANIED WITH PAIN IN HER LEFT ARM. OUT OF CONCERN FOR THE ELEVATED READINGS THE END USER VISITED URGENT CARE. UPON ARRIVAL A BLOOD GLUCOSE TEST WAS PERFORMED WITH THEIR METER AND THE RESULT WAS 373 MG/DL. AN EKG WAS PERFORMED ALONG WITH A BLOOD PRESSURE CHECK. NO TREATMENTS WERE ADMINISTERED TO ASSIST IN STABILIZING HER BLOOD GLUCOSE LEVEL. AFTER 30 MINUTES SHE WAS DISCHARGED AND HER BLOOD GLUCOSE READING REMAINED STEADY AT 373 MG/DL. NO ADDITIONAL DETAILS WERE PROVIDED IN REGARDS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57541 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 73200 - D170608-2 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention ANASTROZOLE| FISH OIL| METFORMIN| VITAMIN D WITH CALCIUM| ZYRTEC| ANASTROZOLE| FISH OIL| METFORMIN| VITAMIN D WITH CALCIUM| ZYRTEC