BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6078324 · Received November 4, 2016

    Report

    Report Number
    3005862821-2016-00101
    Event Type
    Injury
    Date Received
    November 4, 2016
    Date of Event
    October 12, 2016
    Report Date
    October 12, 2016
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 1.5-A. 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 63/60 MG/DL; FOR LEVEL HIGH ARE 249/254 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~80 MG/DL; LEVEL HIGH 190~290 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS.

    Description of Event or Problem · 1

    END USER REPORTED THAT MEDICAL ATTENTION WAS SOUGHT IN (B)(6) 2016 DUE TO INACCURATE READINGS FROM THEIR PRODIGY GLUCOSE METER. END USER FAINTED AND PARAMEDICS WERE CALLED. THE PARAMEDICS PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER BUT THE END USER COULD NOT RECALL THE RESULT. THEY PROCEEDED TO ADMINISTER D5 TO RAISE THE BLOOD GLUCOSE LEVEL ALONG WITH ORANGE JUICE. THE END USER WAS TRANSPORTED TO THE ER AND COULD NOT REMEMBER WHAT TREATMENT WAS ADMINISTERED. DISCHARGE INSTRUCTIONS WERE TO CONTINUE TO MONTIOR HIS BLOOD GLUCOSE AND FOLLOW UP WITH HIS PCP. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730536 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention FUROSEMIDE (LASIX)| LYRICA| NOVOLOG| PANTOPRAZOLE| PANTOPRAZOLE