BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6953835 · Received October 16, 2017

    Report

    Report Number
    3005862821-2017-00104
    Event Type
    Injury
    Date Received
    October 16, 2017
    Date of Event
    September 7, 2017
    Report Date
    September 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
    NY, 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 0.8UA. 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:D160318-1 ). THE CONTROL SOLUTION TESTS FOR LEVEL LOW ARE 131/138 MG/DL, FOR LEVEL HIGH ARE 372/360 MG/DL.THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~80 MG/DL; LEVEL HIGH 210~310 MG/DL. ALL RESULTS WERE OUT OF THE ACCEPTANCE RANGE. NG WE TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND RETAIN STRIPS FROM OUR WAREHOUSE (SAME BATCH AS PATIENT'S STRIPS,LOT #D160318-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 54/54 MG/DL; FOR LEVEL HIGH WERE 262/255 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~80 MG/DL; LEVEL HIGH 210~310 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS. ACCORDING TO ABOVE TESTS, WE FOUND THE METER WAS OPERATED WITHIN SPECIFICATION BUT RESULT OF INCORRECT READINGS FROM PATIENT'S STRIP 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 7:30 AM AFTER THE END USER RECEIVED HIGHER THAN NORMAL BLOOD GLUCOSE READINGS FROM HIS PRODIGY DIABETES METER. THE END USER PERFORMED A BLOOD GLUCOSE TEST AROUND 2:00 AM WITH A RESULT OVER 500 MG/DL. BASED UPON THE READING HE TOOK 100 UNITS OF HUMALOG TO ASSIST WITH LOWERING HIS BLOOD GLUCOSE AND WAS LATER FOUND UNRESPONSIVE. THE PARAMEDICS WERE CALLED AND UPON ARRIVAL THEY PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND THE READING WAS 34 MG/DL. THE END USER WAS GIVEN GLUCOSE LIQUID AND TRANSPORTED TO THE ER. UPON ARRIVAL TO THE ER HIS BLOOD GLUCOSE READING WAS 134 MG/DL AND WAS ADMINISTERED AN ADDITIONAL GLUCOSE SOLUTION. AFTER 3 HOURS IN THE ER HE WAS DISCHARGED WITH A BLOOD GLUCOSE READING OF 134 MG/DL AND INSTRUCTED TO FOLLOW HIS DAILY ROUTINE AND ENSURE THAT HIS PRODIGY DIABETES METER IS WORKING PROPERLY. NO ADDITIONAL DETAILS WERE PROVIDED IN REGARDS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733048 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800 - D160318-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention COSOPT DROP 2X A DAY| HUMALOG : BASED ON BGT| HYDROCHLOROTHIAZIDE 25MG ONCE A DAY| LANTUS : 75UNITS DAILY| LATERAL 8/20MG 2X A DAY| LIPITOR (GENETIC) ONCE A DAY 10MG| LOPRESSOR (GENETIC) 100MG 2X A DAY| NOVOLOG: 30UNITS BGT/3 = 10 UNITS| WARFARIN TABLETS 5MG ONCE A DAY