BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 8369306 · Received February 26, 2019

    Report

    Report Number
    3005862821-2019-00014
    Event Type
    Injury
    Date Received
    February 26, 2019
    Date of Event
    January 17, 2019
    Report Date
    January 31, 2019
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384840518858
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 (B)(4) ON 12/29/2016. THE STRIP LOT # D161129-1 WAS MANUFACTURED ON 11/29/2016 AND EXPIRED IN 11/2018. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS. WE TESTED THE RETAIN STRIPS OF SAME BATCH (D161129-1) WITH OUR IN HOUSE METER AND CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 53/55 MG/DL; FOR LEVEL HIGH WERE 246/237 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. THE STRIP #D161129-1 WAS MANUFACTURED IN NOV. 2016 AND EXPIRED IN NOV. 2018. PATIENT USED EXPIRED STRIPS TO TEST BLOOD WHICH MIGHT CAUSED OR CONTRIBUTED TO ERROR READINGS. USER STORAGE OR OPERATION ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AROUND 7:30-7:45AM. END-USER ALLEGES THAT THE METER GAVE A RESULT OF 48MG/DL AND THE END-USER BECAME UNRESPONSIVE WHICH PROMPTED A CALL TO EMS. END-USER STATED THAT SHE RECEIVED A READING OF 48MG/DL. HER MOTHER IN LAW CALLED PARAMEDICS 5 MINUTES LATER WHEN THE END-USER PASSED OUT. NO FURTHER TESTS WERE PERFORMED WITH THE PRODIGY METER. PARAMEDICS ARRIVED WITHIN 10 MINUTES AND TESTED WITH THEIR METER AND RECEIVED A READING OF 21MG/DL. NO FOOD DRINK OR MEDICATIONS WERE CONSUMED WHILE WAITING ON THE PARAMEDICS. PARAMEDICS STARTED AND IV OF A GLUCOSE SOLUTION AND THE END-USER WAS TRANSPORTED TO (B)(6). UPON ARRIVAL THE END-USERS BLOOD GLUCOSE WAS 40MG/DL. END-USER STATED THAT NO OTHER TESTS WERE PERFORMED AT THE HOSPITAL OR BY PARAMEDICS. END-USER WAS NOT ADMITTED TO THE HOSPITAL AND WAS DISCHARGED 5 HOURS LATER WITH A BLOOD GLUCOSE OF 100MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164198 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D161129-1 00384840518858

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention