BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 19571364 · Received June 19, 2024

    Report

    Report Number
    3005862821-2024-00009
    Event Type
    Injury
    Date Received
    June 19, 2024
    Date of Event
    May 31, 2024
    Report Date
    June 14, 2024
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841518505
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    1.NO NONCONFORMANCE WAS FOUND AND RECORDED IN THE DOCUMENT (B)(4) AFTER OKB REVIEWED DEVICE HISTORY RECORD (DHF) OF THE RETURNED METER (SERIAL (B)(6) AND STRIPS (LOT#: D230619B-4). 2.THE RETURNED METER THAT WAS SHIPPED TO PDC ON (B)(6) 2022 AND THE RETAINED ONE (SERIAL (B)(6) WERE USED TO RE-EXAMINE THEIR SETTING AND ALL FUNCTIONS, AND NO MALFUNCTION OF BOTH METERS OCCURRED. STANDBY CURRENT (3.5 UA) OF THE SUSPECTED METER MET ACCEPTANCE CRITERIA (< 55 UA). 3.THE RETURNED STRIPS WITH 2-YEARS SHELF LIFE WERE MANUFACTURED ON 2023-06-19. THE RETURNED STRIPS AND RETAINED STRIPS WITH US WERE RE-TESTED BY USING RETURNED METERS WITH ANY VALID CONTROL SOLUTIONS (BATCH# OF LEVEL LOW: 2AH1A04 AND EXP. BY 2025-01-31; BATCH# OF LEVEL HIGH: 2AH3A19 AND EXP. BY 2025-01-31), THE RETURNED STRIPS TEST RESULTS (LEVEL LOW: 130/125; LEVEL HIGH: 370/404) WERE OUT THE ACCEPTANCE CRITERIA (LEVEL LOW: 40~85; LEVEL HIGH: 230~340). THE RETAINED STRIPS TEST RESULTS (LEVEL LOW: 75/76; LEVEL HIGH: 332/332) MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 40~85; LEVEL HIGH: 230~340). 4.DESICCANTS OF RETAINED STRIPS FROM OKB'S WAREHOUSE WERE STILL FUNCTIONAL (ORANGE COLOR), AND TESTING RESULTS ABOVE MET THE CRITERIA. HOWEVER, DESICCANTS OF RETURNED STRIPS FROM PATIENT WERE BECOME GREEN COLOR, WHICH MEANS THE STRIPS MIGHT GET MOISTURE, AND MIGHT PRODUCE INCORRECT HIGH RESULTS. WARNING INFORMATION REGARDING CLOSE THE VIAL LID OF STRIPS IMMEDIATELY WAS DISCLOSED IN USER'S MANUAL, STRIP BOX AND VIAL LABEL. THEREFORE, USER'S IMPROPER STORAGE AND PRESERVATION MOSTLY CAUSED THE MALFUNCTION OF THE DEVICE.

    Description of Event or Problem · 0

    CALLER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2024-AROUND 7:00AM AT HOME. CALLER STATED THAT SHE TESTED HER BLOOD GLUCOSE WITH HER PRODIGY METER AND RECEIVED A READING OF 295MG/DL. A NORMAL READING FOR THAT TIME OF DAY IS USUALLY AROUND 150MG/DL. CALLER STATED THAT SHE CALLED HER DOCTOR DUE TO GETTING A HIGH READING AND WAS TOLD TO GO TO THE ER. CALLER STATED THAT SHE ATE A BREAKFAST OF EGGS, BREAD AND BUTTER. SHE ALSO STATED THAT SHE TOOK HER DAILY MEDICATIONS PRIOR TO GOING TO THE ER AT 12 PM. CALLER STATED THAT SHE THEN WENT TO (B)(6) HEALTH LOCATED AT (B)(6). . SHE STATED THAT WHEN SHE ARRIVED HER BLOOD GLUCOSE WAS 152MG/DL. CALLER STATED THAT SHE DID NOT RECEIVE ANY TREATMENT TO RAISE OR LOWER HER BLOOD GLUCOSE. CALLER STATED THAT SHE WAS GIVEN A SCAN OF HER STOMACH BUT DECLINED TO STATE WHY. THERE WAS NO CHANGE TO HER BLOOD GLUCOSE WHEN SHE WAS DISCHARGED FROM WHEN SHE ARRIVED AT THE HOSPITAL. CALLER STATED THAT SHE WAS AT THE HOSPITAL FOR THREE HOURS. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1578374 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D230619B-4 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male ATORVASTATIN| CHLORTHALIDONE| DIGOXIN| ELIQUIS| GLIMEPIRIDE| LOSARTAN| MAGNESIUM| METFORMIN| METOPROLOL| TAMSULOSIN