BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 9494147 · Received December 19, 2019

    Report

    Report Number
    3005862821-2019-00070
    Event Type
    Injury
    Date Received
    December 19, 2019
    Date of Event
    November 10, 2019
    Report Date
    November 22, 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
    FL, 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 08/11/2017. THE STRIP LOT # D190110-2 WAS MANUFACTURED ON 01/10/2019 AND EXPIRED IN 01/10/2021. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS. WE TEST THE RETAIN STRIPS WITH OUR IN HOUSE METER AND CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 49/52 MG/DL; FOR LEVEL HIGH WERE 253/262 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 40~90 MG/DL; LEVEL HIGH 240~350 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 1:30PM IN HER CAR. END-USER STATED THAT SHE TESTED HER BLOOD GLUCOSE WITH HER PRODIGY METER AND RECEIVED A RESULT OF HI MG/DL, SO SHE TOOK HER INSULIN. THE END-USER STATED THAT SHE TESTS 5 TIMES A DAY AND A NORMAL RESULT FOR HER FOR THAT TIME OF DAY IS AROUND 86MG/DL. SHE SAID AS HER GRANDDAUGHTER WAS DRIVING HER HOME AND SHE STARTED TO FEEL ILL. HER GRANDDAUGHTER THE PULLED OVER AND CALLED EMS ABOUT 10-15-MINUTE A AFTER SHE TESTED HER BLOOD GLUCOSE . EMS ARRIVED WITHIN 5 MINUTES AND TESTED HER BLOOD GLUCOSE WITH THEIR METER AND RECEIVED A RESULT OF 39MG/DL. THERE WERE NO FOODS OR MEDICATIONS TAKEN WHILE WAITING FOR THE EMS TO ARRIVE. THE ENDUSER STATED THAT THE EMS GAVE HER GLUCOSE TABLETS AND TRANSPORTED HER TO (B)(6) ER LOCATED AT (B)(6). UPON ARRIVING AT THE HOSPITAL HER BLOOD GLUCOSE WAS 59MG/DL. SHE WAS GIVEN MORE GLUCOSE TABLETS AND PEANUT BUTTER AND APPLE JUICE TO RAISE HER BLOOD GLUCOSE. SHE WAS NOT ADMITTED BUT WAS AT THE HOSPITAL FOR 2 HOURS AND WAS DISCHARGED WITH A BLOOD GLUCOSE OF 124MG/DL. SHE STATED THAT SHE HAS AN INSULIN PUMP BUT DID NOT PROVIDE THE SLIDING SCALE ONLY 125MG/DL OR 30 CARBS - 3 UNITS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1287387 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D190110-2 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization