BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 9517510 · Received December 25, 2019

    Report

    Report Number
    3005862821-2019-00073
    Event Type
    Injury
    Date Received
    December 25, 2019
    Date of Event
    November 18, 2019
    Report Date
    November 27, 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
    MD, 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 11/12/2015. THE STRIP LOT # D190107-2 WAS MANUFACTURED ON 01/07/2019 AND EXPIRED IN 01/07/2021. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS . RETAIN STRIPS TEST. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 67/69 MG/DL; FOR LEVEL HIGH WERE 233/226 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

    CALLER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AROUND 8:30PM AT HOME. CALLER STATED THAT HE WENT TO CHECK ON HIS MOTHER AND NOTICED THAT SHE APPEARED TO HAVE A LOW BLOOD GLUCOSE. HE STATED THAT HE GAVE HER SWEET POTATOES, BAKED CHICKEN, AND ORANGE JUICE. HE STATED THAT SHE THEN BECAME CONFUSED, SO HE CHECKED HER BLOOD SUGAR WITH HER PRODIGY METER AND GOT A RESULT OF 61MG/DL, A NORMAL RESULT FOR HER AT THAT TIME OF DAY IS AROUND 120-300MG/DL(?). HE THEN CALLED EMS WHO ARRIVED IN ABOUT 5 MINUTES. WHEN EMS CHECKED THE END-USERS BLOOD SUGAR THEY RECEIVED A RESULT OF 22MG/DL. THERE WAS ABOUT 6 MINUTES BETWEEN TESTING WITH THE PRODIGY METER AND THE EMS METER. EMS ADMINISTERED AN IV WITH DEXTROSE TO RAISE HER BLOOD SUGAR. SHE WAS NOT TRANSPORTED TO THE HOSPITAL. THE END-USERS BLOOD SUGAR WAS 85MG/DL WHEN THE EMS LEFT HER HOME. SHE DID NOT RECEIVE ANY OTHER TREATMENT. THE CALLER STATED THAT AFTER SEEKING MEDICAL ATTENTION HER INSULIN WAS CHANGED FROM NOVOLIN 70/30: 30 UNITS MORNING 10 UNITS AT NIGHT TO NOVOLIN 70/30: 25 UNITS IN THE MORNING AND 0-10 UNITS AT NIGHT DEPENDING ON HER BLOOD GLUCOSE LEVEL ON A SLIDING SCALE. CALLER DOES NOT HAVE THE SLIDING SCALE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1312539 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D190107-2 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization