BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 9543424 · Received January 3, 2020

    Report

    Report Number
    3005862821-2020-00001
    Event Type
    Injury
    Date Received
    January 3, 2020
    Date of Event
    November 26, 2019
    Report Date
    December 5, 2019
    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 EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. WE TESTED THE STANDBY CURRENT OF RETURNED METER, THE RESULT WAS 1.6A. 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: D171123-2). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 146/161 MG/DL, FOR LEVEL HIGH WERE 304/317 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~80 MG/DL; LEVEL HIGH 200~310 MG/DL. 3 RESULTS WERE OUT OF THE ACCEPTANCE RANGE IN 4 TESTING. DESICCANT COLOR INSIDE THE RETURNED BOTTLE HAD CHANGED. WE TESTED THE RETAIN STRIPS FROM OUR WAREHOUSE (STRIP LOT NUMBER: D171123-2). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 73/70 MG/DL; FOR LEVEL HIGH WERE 254/252 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~80 MG/DL; LEVEL HIGH 200~310 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS . PATIENT'S STRIPS GET DAMP AND EXPIRED. PATIENT USED EXPIRED STRIPS TO TEST BLOOD WHICH MIGHT CAUSED OR CONTRIBUTED TO ERROR READINGS. USER STORAGE OR OPERATION ISSUE.

    Description of Event or Problem · 1

    END-USER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AROUND 6:00PM AT HOME. END-USER STATED THAT SHE TESTED WITH THE PRODIGY METER RECEIVED A RESULT OF 172 MG/DL, WHICH CAUSED HER TO TAKE SOME INSULIN. END-USER TAKES HER INSULIN BASED ON HOW MANY CARBS SHE EATS AND DOES NOT REMEMBER HOW MUCH INSULIN SHE TOOK. A NORMAL RESULT FOR HER AROUND THAT TIME OF DAY IS AROUND 80-100MG/DL. SHE STATED THAT SHE STARTED SWEATING AND WAS JUST CONFUSED. SHE SAID HER SON THEN TESTED HER BLOOD GLUCOSE WITH A CONTOUR METER AND IT READ 23 MG/DL. WHEN THE END-USER'S SON TESTED WITH THE PRODIGY METER AGAIN IT READ 152 MG/DL. HER SON THEN CALLED THEN PARAMEDICS. PARAMEDICS ONLY CHECKED HER BLOOD PRESSURE WHICH WAS 120/68, SHE SAID HER SON GAVE HER SOME FOOD TO RAISE HER BLOOD SUGAR. AFTER HER SON GAVE HER FOOD, THE PARAMEDICS TESTED WITH THE CONTOUR METER AGAIN AND HER RESULT CAME UP TO 79 MG/DL. PARAMEDICS DID NOT TEST HER BLOOD GLUCOSE ON THEIR METER. THE END-USER STATED THAT SHE WAS NOT TRANSPORTED TO THE HOSPITAL AND PARAMEDICS LEFT AFTER TESTING HER BLOOD SUGAR WITH HER CONTOUR METER. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6435 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D171123-2 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR