BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 7863431 · Received September 11, 2018

    Report

    Report Number
    3005862821-2018-00041
    Event Type
    Injury
    Date Received
    September 11, 2018
    Date of Event
    August 2, 2018
    Report Date
    August 23, 2018
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384840518858
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. WE TESTED THE STANDBY CURRENT OF RETURNED METER, THE RESULT WAS 1.2MA. THE CRITERIA IS <55MA. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. WE TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND IN HOUSE STRIPS (STRIP LOT NUMBER:(B)(4)). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 61/62 MG/DL, FOR LEVEL HIGH WERE 259/251 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~85 MG/DL; LEVEL HIGH 210~320 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS. BECAUSE PATIENT DID NOT SEND BACK HER STRIP, SO WE TESTED THE RETAIN STRIPS OF SAME BATCH FROM OUR WAREHOUSE (STRIP LOT NUMBER:(B)(4)). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 61/61 MG/DL; FOR LEVEL HIGH WERE 254/246 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 40~90 MG/DL; LEVEL HIGH 210~320 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS .

    Description of Event or Problem · 1

    REPORTER ALLEGED THAT ON (B)(6) 2018 AT APPROXIMATELY 0900 THE END-USER REQUIRED MEDICAL INTERVENTION DUE TO HYPOGLYCEMIA. REPORTER STATED THAT THE END-USER WAS FOUND UNCONSCIOUS AND BREATHING ON THE FLOOR. REPORTER PERFORMED A BLOOD GLUCOSE TEST WITH THE PRODIGY METER AND THE RESULT REPORTED WAS 374 MG/DL. REPORTER CONTACTED THE PARAMEDICS IMMEDIATELY AFTER TESTING AND THEY ARRIVED APPROXIMATELY 30 MINUTES LATER. WHEN THE PARAMEDICS TESTED THE END-USER'S BLOOD GLUCOSE ON THEIR METER IT READ 30 MG/DL. PARAMEDICS STARTED AN IV AND GAVE THE END-USER "GLUCOSE THROUGH THE IV". REPORTER DOES NOT KNOW THE NAME OF THE FLUIDS ADMINISTERED. PARAMEDICS REMAINED WITH THE END-USER AND RETEST AFTER ADMINISTERING THE FLUIDS AND THE RESULT WAS 135 MG/DL WITH THE PARAMEDIC'S METER. END-USER WAS NOT TRANSPORTED TO THE HOSPITAL. NO FURTHER INFORMATION WAS PROVIDED IN REGARDS TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706490 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D170822-1 00384840518858

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening| R LANTUS 8 UNITS QAM| LIPITOR| NOVOLOG 4 UNITS QAC| QUINAPRIL