BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 8756813 · Received July 3, 2019

    Report

    Report Number
    3005862821-2019-00026
    Event Type
    Injury
    Date Received
    July 3, 2019
    Date of Event
    May 11, 2019
    Report Date
    May 30, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE PATIENT DID NOT RETURN HER METER, ONLY RETURNED HER TEST STRIPS. SO WE TESTED PATIENT'S STRIPS(STRIP LOT NUMBER: D171101-1 ) WITH OUR IN HOUSE METER AND CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 53/55 MG/DL, FOR LEVEL HIGH WERE 230/238 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. 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)(6) ON 08/14/2013. 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) 2019 AROUND 7:00AM. CALLER REPORTED THAT THE END-USER PERFORMED A BLOOD GLUCOSE TEST ON HER PRODIGY METER AND RECEIVED A RESULT OF 240MG/DL (HER NORMAL RESULT FOR THAT TIME OF DAY IS AROUND 120MG/DL). CALLER STATED THAT ABOUT 5 MINUTES AFTER TESTING THE END-USER GOT OUT OF BED AND FELL TO THE FLOOR. PARAMEDICS WHERE THEN CALLED, UPON ARRIVAL THE PARAMEDICS TESTED THE END-USERS BLOOD GLUCOSE WITH THEIR METER AND RECEIVED A RESULT OF 33MG/DL. WHILE WAITING APPROXIMATELY 10 MINUTES FOR THE PARAMEDICS TO ARRIVE THE END-USER TOOK 2 GLUCOSE TABLETS. THERE WAS APPROXIMATELY 30 MINUTES BETWEEN TESTING WITH THE PRODIGY METER AND THE PARAMEDICS METER. THE END-USER WAS THEN TRANSPORTED TO THE ER WHERE UPON ARRIVAL HER BLOOD GLUCOSE WAS 79MG/DL. THE END-USER WAS GIVEN A SANDWICH AT THE EMERGENCY ROOM. THE END-USER WAS GIVEN A SHOT OF LASIX AND WAS ADMITTED TO THE HOSPITAL FOR 38 HOURS. WHEN THE END-USER WAS DISCHARGED HER BLOOD GLUCOSE WAS 127MG/DL. THE END-USER'S MEDICATION WAS CHANGED UPON DISCHARGE SHE WAS TOLD TO STOP TAKING THE JANUVIA AND HER LANTUS WAS DECREASED FROM 80 UNITS TO 40 UNITS. END-USER TESTS HER BLOOD GLUCOSE 3 TIMES A DAY IN HER FINGER TIPS. END-USER WAS TREATED AT SAN ANTONIO REGIONAL HOSPITAL EMERGENCY ROOM LOCATED AT (B)(6). NO ADDITIONAL DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552813 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D171101-1 00384840518858

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization ASPIRIN| ATENOLOL| ATORVASTATIN| CALCITRIOL| JANUVIA| LANTUS| LASIX| LOSARTAN| NIFEDIPINE| NORCO| SYNTHROID| VITAMIN D| XANAX