BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 9443236 · Received December 10, 2019

    Report

    Report Number
    3005862821-2019-00067
    Event Type
    Injury
    Date Received
    December 10, 2019
    Date of Event
    November 6, 2019
    Report Date
    November 7, 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
    PR, 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 (B)(6) 2018. THE STRIP LOT # D180619-1 WAS MANUFACTURED ON 06/19/2018 AND EXPIRED ON 06/19/2020. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS. WE TESTED THE RETAIN STRIPS WITH OUR IN HOUSE METER AND IN HOUSE CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 50/56 MG/DL; FOR LEVEL HIGH WERE 238/232 MG/DL. THE 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 9:00PM AT HOME. END-USER STATED THAT SHE RECEIVED A RESULT OF 450MG/DL TESTED AGAIN AND RECEIVED A 480MG/DL ON HER PRODIGY METER. SHE STATED THAT TOOK 35 UNITS OF HUMALOG BASED OFF THE RESULT SHE RECEIVED. A NORMAL READING FOR THAT TIME OF DAY IS AROUND 150MG/DL. SHE STATED THAT SHORTLY AFTER TAKING HER INSULIN SHE STARTED TO FEEL NAUSEOUS, SWEATY, DIZZY AND HAD A HEADACHE. THE END-USER SAID SHE THEN WENT TO THE HOSPITAL ON HER OWN SHE DID NOT CALL PARAMEDICS. SHE ATE AN APPLE AND HAD SOME WATER PRIOR TO GOING TO THE HOSPITAL. UPON ARRIVING AT THE HOSPITAL HER BLOOD GLUCOSE WAS 58MG/DL. SHE DID NOT RECEIVE ANY TREATMENT TO RAISE HER BLOOD GLUCOSE. SHE WAS AT (B)(6) CLINIC LOCATED AT (B)(6) FOR 1 HOUR. SHE WAS TOLD TO FOLLOW UP WITH HER PRIMARY DR AND SHE DOES NOT RECALL WHAT HER BLOOD GLUCOSE WAS WHEN SHE WAS DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1242238 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D180619-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization