BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6078307 · Received November 4, 2016

    Report

    Report Number
    3005862821-2016-00093
    Event Type
    Injury
    Date Received
    November 4, 2016
    Date of Event
    September 28, 2016
    Report Date
    September 28, 2016
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    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. THE STANDBY CURRENT TEST IS 1.5UA. THE CRITERIA IS <55UA. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND IN HOUSE STRIPS (STRIP LOT NUMBER: D160526-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW ARE 59/64 MG/DL, FOR LEVEL HIGH ARE 261/260 MG/DL. THE CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~80 MG/DL; LEVEL HIGH 190~290 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS. PATIENT DID NOT RETURN THE SUSPECTED STRIPS, SO WE CAN ONLY VERIFY THE METER QUALITY AND CONFIRM METER IS WITHIN THE SPECIFICATION.

    Description of Event or Problem · 1

    END USER'S WIFE STATED THAT MEDICAL ATTENTION WAS SOUGHT AFTER HER HUSBAND RECEIVED INACCURATE READINGS FROM HIS PRODIGY GLUCOSE METER. PARAMEDICS WERE CALLED ON (B)(6) 2016 AT 5:30 AM DUE TO THE END USER SWEATING PROFUSELY AND FAINTING IN THE RESTROOM. THE READING ON THE PRODIGY METER PRIOR TO CALLING THE PARAMEDICS WAS 160 MG/DL. WHILE WAITING ON THE PARAMEDICS TO ARRIVE THE END USER TOOK 20 UNITS OF LANTUS. NO FURTHER BLOOD TESTING WAS PERFORMED BY THE PARAMEDICS. LIQUID GLUCOSE WAS GIVEN TO THE END USER TO ASSIST IN LOWERING HIS BLOOD GLUCOSE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731714 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800-D151014-1

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention ATENOLOL- BLOOD PRESSURE| GLIMEPIRIDE-DIABETES| INVOKANA- DIABETES| LANTUS- INSULIN| LOSARTAN- ORGANS| LYRICA- NERVE DAMAGE| OMEPRAZOLE- HEART BURN| SIMVASTATIN - CHOLESTEROL