BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6790937 · Received August 13, 2017

    Report

    Report Number
    3005862821-2017-00076
    Event Type
    Injury
    Date Received
    August 13, 2017
    Date of Event
    July 6, 2017
    Report Date
    July 10, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, 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 METER, THE RESULT WAS1.2UA. THE CRITERIA IS <55UA. 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 50/52 MG/DL, FOR LEVEL HIGH WERE 245/243 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. PATIENT DID NOT RETURN HER STRIPS, SO WE TESTED THE SUSPECTED METER WITH RETAIN STRIPS FROM OUR WAREHOUSE (SAME LOT AS PATIENT'S STRIPS, LOT #D160603-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 53/60 MG/DL; FOR LEVEL HIGH WERE 261/259 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

    IT WAS REPORTED THAT THE END USER SOUGHT MEDICAL ATTENTION ON (B)(6)2017 AT 10:00AM BY VISITING HER PCP, AFTER RECEIVING HIGHER THAN NORMAL BLOOD GLUCOSE RESULTS FROM HER PRODIGY DIABETES METER. THE END USER PERFORMED SEVERAL BLOOD GLUCOSE TEST AND RECEIVED THE FOLLOWING READINGS 440 MG/DL AND 531 MG/DL. SHE EXPERIENCED DIZZINESS AND A HEADACHE. THE END USER VISITED HER PCP AND UPON ARRIVAL HER BLOOD GLUCOSE READING WAS 106 MG/DL. NO TREATMENT WAS ADMINISTERED SINCE HER BLOOD GLUCOSE WAS WITHIN NORMAL RANGE. UPON RELEASE HER BLOOD GLUCOSE READING WAS 106 MG/DL AND SHE WAS INSTRUCTED TO SEE A NEUROLOGIST FOR HER HEADACHES. NO ADDITIONAL DETAILS WERE PROVIDED IN RELATIONS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571084 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800 - D160603-1

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention