BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 7668821 · Received July 8, 2018

    Report

    Report Number
    3005862821-2018-00036
    Event Type
    Injury
    Date Received
    July 8, 2018
    Date of Event
    June 15, 2018
    Report Date
    June 27, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. OKB TESTED THE STANDBY CURRENT OF RETURNED METER, THE RESULT WAS 1.1 UA. THE CRITERIA IS <55 UA. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. WE TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND RETURNED STRIPS (STRIP LOT NUMBER:D170310-1 ). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 67/67 MG/DL, FOR LEVEL HIGH WERE 293/278 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 TESTED THE RETAIN STRIPS FROM OUR WAREHOUSE (STRIP LOT NUMBER:D170310-1 ). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 66/69 MG/DL; FOR LEVEL HIGH WERE 290/283 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 .

    Description of Event or Problem · 1

    REPORTER ALLEGED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2018 APPROXIMATELY AT 1100 DUE TO THE PRODIGY METER GIVING HIGH RESULTS. A BLOOD GLUCOSE TEST WAS PERFORMED ON THE PRODIGY METER AND THE RESULT WAS HI, INDICATING THE BLOOD GLUCOSE WAS ABOVE 600 MG/DL. TWO ADDITIONAL TEST WERE PERFORMED ON THE PRODIGY METER AND THE RESULTS WERE HI AND 500 MG/DL. PARAMEDICS WERE CALLED IMMEDIATELY AND ARRIVE IN ABOUT 10 MINUTES. THE END-USER DID NOTHING WHILE WAITING ON THE PARAMEDICS AND DID NOT HAVE ANY SYMPTOMS. PARAMEDICS TESTED THE END-USER'S BLOOD GLUCOSE ON THEIR METER AND RECEIVED A RESULT OF 192 MG/DL, THIS WAS ABOUT 20 MINUTES AFTER INITIALLY TESTING ON THE PRODIGY METER. THE PARAMEDIC THEN TESTED THE END-USER WITH THE PRODIGY METER AND THE RESULT WAS 267 MG/DL. NO TREATMENT WAS PROVIDED BY THE PARAMEDICS AND THE END-USER WAS NOT TRANSPORTED TO THE HOSPITAL. END-USER IS PRESCRIBED ORAL ANTIDIABETICS AND IS NOT ON ANY INSULIN. NO FURTHER INFORMATION WAS PROVIDED REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510831 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D170310-1 00384840518858

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other ASPIRIN 81 MG| CLOPIDOGREL 75 MG| FISH OIL| GABAPENTIN 100 MG| GLIPIZIDE 5 MG| ISOSORBIDE 30 MG| LEVOTHYROXINE 25 MG| LISINOPRIL10 MG| METFORMIN 500 MG| PANTOPRAZOLE 40 MG| PRAVASTATIN 20 MG| PREDNISONE 5 MG| VITAMIN D| ZYRTEC