BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6401706 · Received March 14, 2017

    Report

    Report Number
    3005862821-2017-00025
    Event Type
    Injury
    Date Received
    March 14, 2017
    Date of Event
    February 15, 2017
    Report Date
    February 15, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 (B)(4) ON 09/04/2013. THE STRIP LOT #D151021-1 WAS MANUFACTURED ON 10/21/2015 AND EXPIRED IN 10/2017. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS . WE TESTED THE RETAIN STRIPS OF LOT#D151021-1, THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 64/61 MG/DL; FOR LEVEL HIGH WERE 273/267 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE END USER SOUGHT MEDICAL ATTENTION ON (B)(6) 2016 AT 12:00PM AFTER RECEIVING A HIGH READING FROM HER PRODIGY DIABETES GLUCOSE METER. THE END USER'S BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS 200 MG/DL WHICH CONCERNED HER CHILDREN AND THEY RECOMMENDED THAT SHE SEEK MEDICAL ATTENTION. THERE WERE NO SIGNIFICANT SYMPTOMS RELATED TO THIS EVENT AND IT WAS ALSO DETERMINED THAT THE END USER'S TEST STRIPS HAD BEEN OPEN OVER 90 DAYS. UPON ARRIVAL TO THE ER THE END USER'S BLOOD GLUCOSE WAS 117 MG/DL. NO TREATMENT WAS ADMINISTERED DUE TO THE FACT THAT HER BLOOD GLUCOSE WAS IN A NORMAL RANGE. AFTER 20 MINUTES SHE WAS DISCHARGED FROM THE ER AND NO FURTHER INTERVENTION WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185764 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800 - D151021-1

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention AMLODIPINE 500 MG| ATORVASTATIN 20 MG| BAYER ASPIRIN 325 MG| CARVEDILOL 25 MG/DL| ISOSORBIDE MONONITRATE 30 MG| LASIX| LOSARTAN 100 MG| METFORMIN 500 MG| ONGLYZA 5 MG| POTASSIUM| RANEXA 500MG