BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6157175 · Received December 9, 2016

    Report

    Report Number
    3005862821-2016-00107
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    October 27, 2016
    Report Date
    October 27, 2016
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 1.0UA. THE CRITERIA IS <55UA. PASS; METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK; TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND RETAIN STRIPS (STRIP LOT NUMBER:D160113-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW ARE 55/56 MG/DL, FOR LEVEL HIGH ARE 243/246 MG/DL. THE CONTROL SOLUTION RANGES ARE: LEVEL LOW 25~70 MG/DL; LEVEL HIGH 210~310 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS; TESTED THE RETURNED STRIPS FROM PATIENT (STRIP LOT NUMBER:D160113-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 59/58 MG/DL; FOR LEVEL HIGH WERE 241/262 MG/DL. THE CONTROL SOLUTION RANGES ARE: LEVEL LOW 25~70 MG/DL; LEVEL HIGH 210~310 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE END USER SOUGHT MEDICAL ATTENTION ON (B)(6) 2016 AT 10 PM AFTER RECEIVING A HIGH READING OF 371 MG/DL FROM THE PRODIGY DIABETES GLUCOSE METER. THE END USER FELT WEAK AND THE PARAMEDICS WERE CALLED. THE PARAMEDICS PERFORMED A TEST WITH THEIR METER WITH A RESULT OF 250 MG/DL AND NO TREATMENT WAS PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808785 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800-D160113-1

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention GLIPIZIDE 2.5MG| METFORMIN 500MG| NITRO STAT 0.4 MG