BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 10688470 · Received October 16, 2020

    Report

    Report Number
    3005862821-2020-00057
    Event Type
    Injury
    Date Received
    October 16, 2020
    Date of Event
    September 12, 2020
    Report Date
    October 2, 2020
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841518505
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO NON-CONFORMANCE WAS FOUND AFTER OKB REVIEWED ALL MANUFACTURING AND QC RECORDS OF THE SUSPECTED DEVICE (METER SERIAL#: (B)(4) AND STRIP LOT#: D190729-1). RETURN AND RETAINED STRIPS (LOT#: D190729-1) WERE RE-TESTED BY USING RETURN METER (SERIAL#: (B)(4)) AND RETAINED METER (SERIAL#: (B)(4)) WITH CONTROL SOLUTIONS (LEVEL LOW: BATCH# 8AH1A95, EXP. BY DEC., 2020; LEVEL HIGH: BATCH# 8AH3A15, EXP. BY DEC., 2020), RESPECTIVELY, AND RESULTS WERE SHOWN BELOW. 2.1 RETURN METER W/ RETURN STRIPS: FAILED (LEVEL LOW) AND FAILED (LEVEL HIGH); 2.2 RETURN METER W/ RETAINED STRIPS: FAILED (LEVEL LOW) AND FAILED (LEVEL HIGH); 2.3 RETAINED METER W/ RETURN STRIPS: 74/66 (LEVEL LOW) AND 291/279 (LEVEL HIGH); 2.4 RETAINED METER W/ RETAINED STRIPS: 73/69 (LEVEL LOW) AND 287/269 (LEVEL HIGH); STANDBY CURRENT OF THE SUSPECTED DEVICE WAS RE-CHECKED AND THE CURRENT (7.9 UA) MET ACCEPTANCE CRITERIA (< 55 UA). THE METER SETTING AND ALL FUNCTIONS OF THE SUSPECTED DEVICE WERE RE-TESTED, AND METER WAS NOT ABLE TO TURN ON WHILE INSERTING THE STRIP. THE MALFUNCTION OF THE METER RESULTED FROM DEFORMED PIN OF THE CONNECTOR FROM PATIENT. FROM OUR DESIGN AND TESTS, THE CONNECTOR WAS PASSED INSERTION/WITHDRAWAL TESTING AT LEAST 10,000 TIMES, AND THE METER GUARANTEED TO OPERATE PROPERLY UNDER NORMAL USAGE. THEREFORE, USER'S IMPROPER OPERATION MIGHT CAUSE THE MALFUNCTION OF THE DEVICE.

    Description of Event or Problem · 1

    END-USER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2020 AROUND 2:30PM AT HOME. END-USER STATED THAT SHE TESTED HER BLOOD GLUCOSE WITH HER PRODIGY METER AND RECEIVED A RESULT OF 170MG/DL. A NORMAL RESULT FOR THAT TIME OF DAY IS USUALLY AROUND 100MG/DL. THE END-USER STATED THAT ABOUT 30 MINUTES AFTER TESTING SHE STARTED TO FEEL AS THOUGH HER BLOOD GLUCOSE WAS HIGH AND SHE CALLED PARAMEDICS. THE END-USER STATED THAT SHE STARTED TO FEEL DIZZY, WEAK, HAD A HEADACHE AND FELT AS THOUGH SHE WAS GOING TO PASS OUT. THERE WAS NO FOOD DRINK OR MEDICATION CONSUMED WHILE WAITING FOR PARAMEDICS WHO ARRIVED IN ABOUT 10 MINUTES. PARAMEDICS TESTED HER BLOOD GLUCOSE WITH THEIR METER AND RECEIVED A RESULT OF 489MG/DL. PARAMEDICS DID NOT TEST THE END-USER WITH HER PRODIGY METER. THE END-USER STATED THAT NO TREATMENT WAS RECEIVED BY THE PARAMEDICS AND THEY TRANSPORTED HER TO MOBILE INFIRMARY LOCATED AT 5 MOBILE INFIRMARY CIR, MOBILE, AL 36607. UPON ARRIVING AT THE HOSPITAL, THE END-USERS BLOOD GLUCOSE WAS STILL 489MG/DL. END-USER STATED THAT SHE WAS GIVEN GLUCOSE THROUGH AN IV. AFTER TESTING BLOOD WORK AND URINE THE END-USER WAS GIVEN A PRESCRIPTION FOR A URINARY TRACT INFECTION. THE END-USER STATED THAT SHE WAS AT THE HOSPITAL FOR 7 HOURS AND WAS TOLD TO FOLLOW UP WITH HER PRIMARY CARE DOCTOR. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1158027 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D190729-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization