BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 8963885 · Received September 5, 2019

    Report

    Report Number
    3005862821-2019-00041
    Event Type
    Injury
    Date Received
    September 5, 2019
    Date of Event
    July 31, 2019
    Report Date
    August 12, 2019
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384840518858
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 1.1A. THE CRITERIA IS <55A. 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: D181011-2 ). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 55/53 MG/DL, FOR LEVEL HIGH WERE 254/243 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 TESTED THE RETAIN STRIPS OF SAME BATCH FROM OUR WAREHOUSE (STRIP LOT NUMBER: D181011-2 ) WITH RETURNED METER AND IN HOUSE CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 54/58 MG/DL; FOR LEVEL HIGH WERE 262/265 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 · 1

    CALLER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AROUND 8PM AT THE END-USER'S HOME. CALLER STATED THAT THE END-USER TOOK A BLOOD GLUCOSE TEST AND RECEIVED A RESULT 50MG/DL. A NORMAL RESULT FOR THE END-USER FOR THAT TIME OF DAY IS 150-200MG/DL. PRIOR TO SEEKING MEDICAL ATTENTION, THE END-USER HAD DINNER AND TOOK HIS PRESCRIBED MEDICATIONS. CALLER STATED THAT THE END-USER APPEARED AWAKE BUT WAS NOT RESPONSIVE, SO SHE CALLED EMS. CALLER STATED THAT WHILE WAITING FOR THE ENS TO ARRIVE SHE TRIED TO GIVE THE END-USER CANDY, BUT HE WAS NOT RESPONDING. EMS ARRIVED 10-15 MINUTES AFTER TESTING WITH THE PRODIGY METER. THEY TESTED THE END-USER WITH THERE METER AND RECEIVED A RESULT OF 30MG/DL. THE END-USER WAS STILL UNRESPONSIVE, AND THE EMS ADMINISTERED A GLUCOSE IV. END-USER WAS THE TRANSPORTED TO (B)(6) HOSPITAL LOCATED AT (B)(6). CALLER WAS UNSURE OF WHAT HIS BLOOD GLUCOSE WAS UPON ARRIVING AT THE HOSPITAL. CALLER WAS UNABLE TO PROVIDE WHAT TREATMENT THE END-USER RECEIVED DUE TO NOT BE ALLOWED IN THE BACK ANT THE ER. SHE STATED THAT HE WAS NOT ADMITTED AND WAS THERE APPROXIMATELY 8 HOURS. CALLER WAS UNABLE TO RECALL WHAT THE END-USERS BLOOD GLUCOSE WAS WHEN HE WAS DISCHARGED OR WHAT INSTRUCTIONS HE MAY HAVE RECEIVED. THE END -USER IS ON A SLIDING SCALE THAT IS AS FOLLOWS TRESIBA: 20 UNITS IN THE MORNING. NOVOLOG: SLIDING SCALE, 150-200MG/DL=1 UNIT, 201-250MG/DL=2 UNITS, 251-300MG/DL=3 UNITS, 301- 350MG/DL=4 UNITS, 351-400MG/DL=5 UNITS, 401-450MG/DL=6 UNITS, AND CALL EMT IF RESULT IS BELOW 70 MG/DL OR OVER 450 MG/DL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760412 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D181011-2 00384840518858

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization