BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY VOICE

    MDR report key: 8774946 · Received July 10, 2019

    Report

    Report Number
    3005862821-2019-00031
    Event Type
    Injury
    Date Received
    July 10, 2019
    Date of Event
    June 12, 2019
    Report Date
    July 2, 2019
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384840519008
    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 WE TESTED THE STANDBY CURRENT OF RETURNED METER, THE RESULT WAS 12.3¿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 RETURNED STRIPS (STRIP LOT NUMBER: D180713-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 61/62 MG/DL, FOR LEVEL HIGH WERE 269/270 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~85 MG/DL; LEVEL HIGH 230~340 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS. WE TESTED THE RETAIN STRIPS FROM OUR WAREHOUSE (SAME AS PATIENT'S STRIP, LOT NUMBER: D180713-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 60/60 MG/DL; FOR LEVEL HIGH WERE 269/267 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~85 MG/DL; LEVEL HIGH 230~340 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AROUND 4:30PM. THE END-USER STATED THAT HE TOOK A BLOOD GLUCOSE TEST WITH HIS PRODIGY METER AND RECEIVED A 81MG/DL. HEW STATED THAT HE FELT AS THOUGH HIS BLOOD GLUCOSE WAS LOW, SO HE CALLED PARAMEDICS. A NORMAL READING FOR THE END-USER AT THAT TIME OF DAY IS AROUND 176- 200MG/DL. THE END-USER CALLED THE PARAMEDICS ABOUT 20 MINUTES AFTER TESTING. THE PARAMEDICS ARRIVED WITHIN 5 MINUTES AND TESTED HIS BLOOD GLUCOSE AND RECEIVED A RESULT OF 41MG/DL. THE END-USER STATED THAT HE TOOK 2 SUGAR PILLS WHILE WAITING FOR THE PARAMEDICS TO ARRIVE. THE END-USER WAS NOT TRANSPORTED TO THE HOSPITAL. HE HAD 2 COKES AND A PIZZA WHILE PARAMEDICS WERE THERE. END-USER WAS NOT AWARE OF WHAT HIS BLOOD GLUCOSE WAS BEFORE THE PARAMEDICS LEFT HIS HOME. HE WAS UNABLE TO PROVIDE HIS MEDICATION LIST AND ATTEMPTS WERE MADE TO RETRIEVE THIS INFORMATION BUT WERE UNSUCCESSFUL. NO ADDITIONAL DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568281 PRODIGY VOICE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51900 D180713-1 00384840519008

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention LANTUS 55 UNITS