BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 8987596 · Received September 11, 2019

    Report

    Report Number
    3005862821-2019-00044
    Event Type
    Injury
    Date Received
    September 11, 2019
    Date of Event
    August 7, 2019
    Report Date
    August 13, 2019
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384840518858
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 02/15/2017. THE STRIP LOT # D190201-2 WAS MANUFACTURED ON FEB. 01, 2019 AND EXPIRED IN FEB. 01, 2021. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS. WE TESTED THE RETAIN STRIPS OF SAME BATCH WITH OUR IN HOUSE METER AND CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 60/59 MG/DL; FOR LEVEL HIGH WERE 240/232 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~85 MG/DL; LEVEL HIGH 200~310 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

    END-USER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AROUND 5:00 PM AT HER HOME. END-USER STATED THAT HER PRODIGY METER GAVE HER A RESULT OF 291 MG/DL AND ABOUT 10 MINUTES AFTER THAT SHE STARTED TO FEEL DIZZY AND HER FINGERS GOT NUMB SO SHE CALLED THE PARAMEDICS. PARAMEDICS ARRIVED WITHIN 15 MINUTES AND TESTED WITH THEIR METER AND GOT A RESULT OF 115 MG/DL. PARAMEDICS DID NOT PROVIDE ANY TREATMENT FOR HER BLOOD GLUCOSE LEVEL; HOWEVER, THEY DID TRANSPORT HER TO THE HOSPITAL DUE TO HER BLOOD PRESSURE BEING HIGH. END-USER DOES NOT RECALL WHAT HER BLOOD GLUCOSE WAS UPON ARRIVING AT THE HOSPITAL. END-USER STATED THE HOSPITAL TESTED HER URINE AND BLOOD PRESSURE. SHE WAS TOLD SHE HAS A BLADDER INFECTION AND HER BLOOD PRESSURE IS HIGH, BUT SHE DOES NOT RECALL WHAT THE NUMBERS WERE. SHE WAS INSTRUCTED TO FOLLOW UP WITH HER PRIMARY DR. ENDUSER STATED THAT SHE WAS NOT ADMITTED SHE WAS DISCHARGED AFTER ABOUT 3 HOURS. THE END-USER WAS TREATED AT (B)(6) MEDICAL CENTER LOCATED AT (B)(6). NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784883 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D190201-2 00384840518858

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization