BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6621208 · Received June 8, 2017

    Report

    Report Number
    3005862821-2017-00050
    Event Type
    Injury
    Date Received
    June 8, 2017
    Date of Event
    May 12, 2017
    Report Date
    May 12, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 1.0UA. 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 60/55 MG/DL, FOR LEVEL HIGH WERE 236/252 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW30~80 MG/DL; LEVEL HIGH 190~290 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS BECAUSE PATIENT DID NOT RETURNED HER STRIPS (THE STRIP BOTTLE WE RECEIVED FROM PATIENT WERE EMPTY), SO WE TESTED THE SAME BATCH OF RETAIN STRIPS (LOT NUMBER:D160309-1) FROM OUR WAREHOUSE. THE CONTROL SOLUTION TEST RESULTS OF OUR RETAIN STRIPS FOR LEVEL LOW WERE 58/61 MG/DL; FOR LEVEL HIGH WERE 292/284 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE END USER SOUGHT MEDICAL ATTENTION ON (B)(6)2017 AT 2:10 PM AFTER RECEIVING HIGHER THAN NORMAL BLOOD GLUCOSE TEST FROM HER PRODIGY DIABETES METER. THE END USER EXPERIENCED NERVOUSNESS, STOMACH PAIN AND A BLOOD GLUCOSE READING OF 598 MG/DL. THE END USER WAS TAKEN TO THE ER AND UPON ARRIVAL HER BLOOD GLUCOSE WAS 96 MG/DL. NO TREATMENT WAS ADMINISTERED AND AFTER 20 MINUTES IN THE ER THE END USER WAS DISCHARGED WITH A BLOOD GLUCOSE READING OF 97 MG/DL. NO FURTHER DETAILS WERE PROVIDED IN RELATIONS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402770 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 54800 - D160309-1

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention CARVEDILOL 12.5 MG TWICE A DAY| ESOMETROZOLE 40 MG ONCE A DAY A DAY| LANTUS 40-50 UNITS AT NIGHT| LASIX 40 MG ONCE A DAY OR TWICE IF NEEDED| NOVOLOG 8 UNITS AM 13 UNITS AT LUNCH 15 UNITS PM| PLAQUEMIL 200 MG ONCE A DAY| PLAVIX 75 MG ONCE A DAY| POTASSIUM CHLORIDE 8 MG ONCE A DAY| PREVASTATIN 20 MG ONCE A DAY| SPIRONOLACPONE 25 MG ONCE A DAY| SYNTHROID 88 MCG TAB ONCE A DAY| TRAMADOL 50 MG 1 EVERY 6 HOURS AS NEEDED| VALSARTAN HCT 320 MG 1/2 TAB A DAY