BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 9543436 · Received January 3, 2020

    Report

    Report Number
    3005862821-2020-00002
    Event Type
    Injury
    Date Received
    January 3, 2020
    Report Date
    December 9, 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
    LA, 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 04/20/2017. THE STRIP LOT #D190521-1 WAS MANUFACTURED ON 05/21/2019 AND EXPIRED IN 05/21/2021. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS. 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 BUT SHE WAS UNSURE OF THE DATE, BUT THE TIME WAS AROUND 5:30PM AT HOME. END-USER CONTACTED PRODIGY ON (B)(6) 2019 AND WHEN ASKED SHE STATED THAT SHE DID NOT SEEK ANY MEDICAL ATTENTION. WHEN SHE CALLED BACK TO FOLLOW UP FOR TROUBLESHOOTING ON (B)(6) 2019 SHE THEN STATED THAT SHE SOUGHT MEDICAL ATTENTION ABOUT 3 WEEKS AGO. SHE WAS UNSURE OF THE DATE THAT SHE CALLED PARAMEDICS. SHE STATED THAT SHE TESTED HER BLOOD GLUCOSE AND RECEIVED A RESULT OF 400MG/DL. SHE STATED THAT SHE THEN TOOK AN ADDITIONAL TEST AND RECEIVED THE SAME RESULT. THE END-USER SAID SHE THEN CALLED PARAMEDICS WHO ARRIVED WITHIN 20 MINUTES. UPON ARRIVAL PARAMEDICS TESTED HER BLOOD GLUCOSE WITH THEIR METER AND RECEIVED A RESULT OF 260MG/DL. THE END-USER STATED THAT SHE DID NOT GET ANY KIND OF TREATMENT FROM PARAMEDICS. THE END-USER STATED THAT SHE WENT TO THE HOSPITAL ON HER OWN AND WHEN SHE ARRIVED HER BLOOD GLUCOSE WAS 58MG/DL. THE END-USER SAID SHE WAS GIVEN AN IV GLUCOSE SOLUTION A BOWL OF CEREAL WITH MILK AND ORANGE JUICE AT THE HOSPITAL. SHE STATED THAT SHE WAS AT THE HOSPITAL FOR 10 HOURS, BUT SHE WAS NOT ADMITTED. THE END-USER WAS TREATED AT (B)(6) LOCATED AT (B)(6). THE END-USER IS ON A SLIDING SCALE FOR HER INSULIN THAT GOES AS FOLLOWS HUMALOG 3 TIMES A DAY: SLIDING SCALE: 150-201MG/DL 4 UNITS, 202-251MG/DL 6 UNITS, 252-301MG/DL 8 UNITS, 302-400MG/DL 12 UNITS, ABOVE 400MG/DL CALL THE DOCTOR. NO ADDITIONAL DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6820 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D190521-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization