BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6600318 · Received May 31, 2017

    Report

    Report Number
    3005862821-2017-00044
    Event Type
    Injury
    Date Received
    May 31, 2017
    Date of Event
    April 24, 2017
    Report Date
    April 25, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE AND STRIPS WERE RETURNED AND EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS BUT STRIPS WERE MOIST. WE TESTED THE STANDBY CURRENT OF RETURNED METER, THE RESULTS WAS 1.2UA. 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 RETURNED STRIPS (STRIP LOT NUMBER: D160809-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WAS 148 MG/DL, FOR LEVEL HIGH WAS 310 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~80 MG/DL; LEVEL HIGH 190~290 MG/DL. ALL RESULTS WERE OUT OF THE ACCEPTANCE RANGE. WE TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND RETAIN STRIPS IN OUR WAREHOUSE (SAME BATCH AS PATIENT'S STRIPS, LOT #D160809-1).THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 55/56 MG/DL; FOR LEVEL HIGH WERE 262/266 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 . ACCORDING TO ABOVE TESTS, WE FOUND THE RESULT OF INCORRECT READINGS FROM PATIENT MIGHT BECAUSE PATIENT STORED THE STRIPS IN A UNCONTROLLED OR IMPROPER ENVIRONMENT AND LEAD TO STRIPS MOIST AND PRODUCED INCORRECT HIGH READINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2017 AT 1:30PM AFTER THE END USER RECEIVED HIGHER THAN NORMAL BLOOD GLUCOSE RESULTS FROM HIS PRODIGY DIABETES METER. THE END USER STATED THAT HE CHECKED HIS BLOOD GLUCOSE AND RECEIVED A RESULT OF 221 MG/DL. HE PROCEEDED TO TAKE AN UNSPECIFIED AMOUNT OF INSULIN. HIS SPEECH BECAME SLURRED ALONG WITH BLURRY VISION AND UNCONTROLLABLE BODY MOVEMENTS. THE PARAMEDICS WERE CALLED AND PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND THE READING WAS 32 MG/DL. HE RECEIVED GLUCOSE GEL AND WAS TRANSPORTED TO THE ER. ONCE AT THE ER HE RECEIVED ADDITIONAL GLUCOSE GEL TO ASSIST WITH STABILIZING HIS BLOOD GLUCOSE LEVELS. AFTER 3 HOURS IN THE ER HE WAS DISCHARGED WITH A BLOOD GLUCOSE READING OF 140 MG/DL. NO FURTHER DETAILS WERE PROVIDED IN RELATIONS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383771 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D160809-1

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention NOVOLIN 20 UNITS