BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY VOICE

    MDR report key: 8863538 · Received August 6, 2019

    Report

    Report Number
    3005862821-2019-00032
    Event Type
    Injury
    Date Received
    August 6, 2019
    Date of Event
    July 1, 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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. 1. WE TESTED THE STANDBY CURRENT OF RETURNED METER, THE RESULT WAS 13.5 A. THE CRITERIA IS <55 A. PASS. 2. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. 3. WE TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND RETURNED STRIPS (STRIP LOT NUMBER:D180907-2 ). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 54/58 MG/DL, FOR LEVEL HIGH WERE 236/235 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~85 MG/DL; LEVEL HIGH 210~320 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS. 4. WE TESTED THE RETAIN STRIPS (SAME AS PATIENT'S STRIP LOT NUMBER:D180907-2 ) WITH SUSPECTED METER AND OUR IN HOUSE CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 55/59 MG/DL; FOR LEVEL HIGH WERE 241/244 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~85 MG/DL; LEVEL HIGH 210~320 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS.

    Description of Event or Problem · 0

    THIS IS A SUPPLEMENTAL REPORT TO INITIAL REPORT 3005862821-2019-00032 TO SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICES. DEVICES WERE RETURNED FROM PRODIGY DIABETES CARE ON (B)(6) 2019 AND AN INVESTIGATION RESULTS OF THE SUSPECT DEVICES WERE COMPLETED BY OK BIOTECH.

    Additional Manufacturer Narrative · 1

    BECAUSE DEVICE WAS NOT RETURNED TO OK BIOTECH, THEREFORE, WE WERE UNABLE TO PERFORM FURTHER TESTING ON THE SUSPECTED DEVICE. OK BIOTECH REVIEWED THE MANUFACTURING RECORD OF THIS SUSPECTED DEVICE (METER SERIAL NUMBER # (B)(4)), AND THE METER WAS QUALIFIED AND RELEASED BY THE QUALITY CONTROL DEPARTMENT AND SHIPPED TO (B)(6) ON 06/24/2015. THE STRIP LOT # D180907-2 WAS MANUFACTURED ON SEP. 07, 2018 AND EXPIRED IN SEP. 07, 2020. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS. WE TESTED THE RETAIN STRIPS OF SAME BATCH WITH OUR IN HOUSE METER AND CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 55/54 MG/DL; FOR LEVEL HIGH WERE 238/232 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~85 MG/DL; LEVEL HIGH 210~320 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS . WE ARE UNABLE TO CONFIRM THE COMPLAINT BECAUSE DEVICE WAS NOT RETURNED AND NO FURTHER INFORMATION FROM CUSTOMER HAS BEEN RECEIVED, THIS MATTER HAS TO BE CLOSED OUT WITH UNDETERMINED ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AT 2:30AM AT THE END-USER'S HOME. THE CALLER STATED THAT THE END-USER WOKE UP AND FELT ILL. HE THEN PERFORMED A BLOOD GLUCOSE TEST AND RECEIVED A 76MG/DL. REPORTER STATED THAT SHE THEN CALLED THE PARAMEDICS DUE TO HIM NOT FEELING WELL. PARAMEDICS WERE CALLED 10 MINUTES AFTER TESTING WITH HIS PRODIGY METER. REPORTER STATED THAT HE HAD APPLE JUICE AND SUGAR WHILE WAITING FOR THE PARAMEDICS TO COME THE PARAMEDICS ARRIVED ABOUT 10 MINUTES LATER AND TESTED HIS BLOOD GLUCOSE AND RECEIVED A RESULT OF 60MG/DL, THEY THEN TESTED WITH THE END-USERS PRODIGY METER AND RECEIVED A RESULT OF 86MG/DL. THE END-USER WAS NOT TRANSPORTED TO THE HOSPITAL. THE PARAMEDICS HAD HIM EAT A PEANUT BUTTER SANDWICH. THE END-USER IS ON A SLIDING SCALE THAT IS AS FOLLOWS: LANTUS: 14 UNITS IN THE MORNING AND 24 UNITS AT NIGHT. NOVOLOG: 10 UNITS (SLIDING SCALE: 150-200MG/DL ADD 2 UNITS, 201-250MG/DL ADD 3 UNITS, 251-300MG/DL ADD 4 UNITS, 351-400MG/DL ADD 6 UNITS). NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659872 PRODIGY VOICE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51900 D180907-2 00384840519008

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention ATOVAROL| CLOPIDOGREL| FINASTERIDE| FLUTICASONE| LOPERAMIDE| METOPROLOL| PANTOPRAZOLE| PRAMIPEXOLE| PROBIOTIC| SEVELAMER| VITAMIN D