BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 9562208 · Received January 8, 2020

    Report

    Report Number
    3005862821-2020-00004
    Event Type
    Injury
    Date Received
    January 8, 2020
    Date of Event
    December 2, 2019
    Report Date
    December 10, 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. WE 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 04/30/2013. 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 TESTED THE RETAIN STRIPS WITH OUR IN HOUSE METER AND CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 60/56 MG/DL; FOR LEVEL HIGH WERE 258/260 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~85 MG/DL; LEVEL HIGH 220~330 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 9:30AM AT HOME. CALLER STATED THAT THE END-USER TESTED HIS BLOOD GLUCOSE WHEN HE WOKE UP AND RECEIVED A RESULT OF 96MG/DL , HIS NORMAL RANGE FOR THAT TIME OF DAY IS AROUND 90-95MG/DL. CALLER STATED THAT THE END-USER TOOK HIS MORNING MEDICATIONS AND SHE LEFT. UPON RETURNING HOME SHE STATED THAT THE END-USER WAS PASSED OUT ON THE FLOOR. SHE THEN CALLED EMS WHO ARRIVED WITHIN 20MINUTES, THEY CHECKED THE END-USERS BLOOD GLUCOSE WITH THEIR METER AND RECEIVED A RESULT OF 30MG/DL. EMS HOOKED END-USER UP TO AN IV TO ADMINISTER A GLUCOSE SOLUTION. CALLER STATED THAT THEY EMS DID TEST TO ENSURE THE END-USER WAS NOT HAVING A STROKE. NO OTHER TREATMENT OR TESTS WERE PERFORMED BY THE EMS. THE END-USER WAS NOT TRANSPORTED TO THE HOSPITAL. SHE ALSO STATED THAT NO OTHER TREATMENT OR TESTS WERE PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25783 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D190521-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization