BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6553383 · Received May 9, 2017

    Report

    Report Number
    3005862821-2017-00036
    Event Type
    Injury
    Date Received
    May 9, 2017
    Date of Event
    April 3, 2017
    Report Date
    April 3, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 THE RETURNED METER, 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 IN HOUSE STRIPS (STRIP LOT NUMBER:D160526-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 52/55 MG/DL, FOR LEVEL HIGH WERE 254/254 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2017 AT 5:30PM AFTER THE END USER RECEIVED A BLOOD GLUCOSE READING OF 120 MG/DL FROM HER PRODIGY DIABETES METER. BUT THE END USER DISPLAYED SYMPTOMS ASSOCIATED WITH A LOW BLOOD GLUCOSE LEVEL. THE END USER WAS INCOHERENT, GROANING AND HAD SLURRED SPEECH. THE PARAMEDICS WERE CALLED AND PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND THE RESULT WAS 34 MG/DL. THE END USER WAS GIVEN AN IV OF FLUIDS, SUGAR WATER AND TRANSPORTED TO THE ER. ONCE AT THE ER THE END USER RECEIVED ADDITIONAL IV FLUIDS ALONG WITH DINNER TO ASSIST WITH STABILIZING HER BLOOD GLUCOSE. AFTER 4 HOURS AT THE ER THE END USER WAS DISCHARGED WITH A BLOOD GLUCOSE READING OF 88 MG/DL. SHE WAS INSTRUCTED TO FOLLOW HER DIABETIC DIET AND FOLLOW-UP WITH HER PCP. NO ADDITIONAL INFORMATION WAS PROVIDED IN RELATIONS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334920 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention AMLODIPINE 10 MG 1 TABLET EVERY MORNING| ASPIRIN 81 MG 1 TAB IN THE MORNING| ATENOLOL 25 MG 1 TABLET EVERY 12 HOURS| GLIMEPIRIDE 8 MG 1 IN THE MORNING| HYDRALAZINE 100 MG FOUR TIMES DAILY| IRON SUPPLEMENT 300 MG 3 TIMES A DAY| NOVOLIN 20 UNITS IN THE MORNING| NOVOLIN 25 UNITS AT NIGHT TIME| NOVOLOG 10 UNITS 3 TIMES A DAY E. INITIAL| NYSTATIN 1000U/1GM APPLY ON FEET EVERY 12 HOURS| TERAZOSIN 5 MG ONE AT BEDTIME| TYLENOL 325 MG AS NEEDED