BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 7056646 · Received November 23, 2017

    Report

    Report Number
    3005862821-2017-00125
    Event Type
    Injury
    Date Received
    November 23, 2017
    Date of Event
    October 18, 2017
    Report Date
    October 18, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841518505
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 MEYER, THE RESULT WAS 1.1¿A. THE CRITERIA IS <55¿A. 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:D160526-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 59/59 MG/DL, FOR LEVEL HIGH WERE 250/253 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. BECAUSE PATIENT DID NOT RETURN HER STRIPS OR PROVIDE STRIP LOT INFORMATION, HENCE WE ARE UNABLE TO HAVE FURTHER INVESTIGATION ON TEST STRIPS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT DUE TO THE END USER RECEIVING A HIGH READING OF 380 MG/DL FROM HER PRODIGY DIABETES METER. THE END USER DID NOT EXPERIENCE ANY SIGNIFICANT SYMPTOMS BUT OUT OF CONCERN FOR THE ELEVATED READING, SHE WAS TAKEN TO THE ER. UPON ARRIVAL TO THE ER, HER BLOOD GLUCOSE READING WAS 97 MG/DL. NO TREATMENTS OR ADDITIONAL TESTING WERE WARRANTED SINCE HER BLOOD GLUCOSE LEVEL WAS WITHIN NORMAL RANGE. THE END USER WAS DISCHARGED AND INSTRUCTED TO HAVE HER PRODIGY METER CHECKED FOR ACCURACY. NO ADDITIONAL DETAILS WERE PROVIDED IN REGARDS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835954 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention