BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 24243608 · Received February 3, 2026

    Report

    Report Number
    3005862821-2026-00001
    Event Type
    Malfunction
    Date Received
    February 3, 2026
    Date of Event
    December 1, 2025
    Report Date
    January 16, 2026
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841518505
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    1.NO NONCONFORMANCE WAS FOUND OR RECORDED IN DOCUMENT (B)(4) AFTER OKB REVIEWED THE DEVICE HISTORY RECORD (DHF) OF THE SUSPECTED METER (SERIAL NO.: (B)(6)) AND STRIPS (LOT NO.: D250612A-4). 2.THE SUSPECTED METER SHIPPED TO PDC ON 2024-07-18 AND THE RETAINED METER (SERIAL NO.: (B)(6)) WERE USED TO RE-EXAMINE ALL SETTINGS AND FUNCTIONS. NO MALFUNCTION WAS OBSERVED ON EITHER METER. THE STANDBY CURRENT OF THE SUSPECTED METER WAS 5.2 A, WHICH MET THE ACCEPTANCE CRITERION (<55 A). 3.THE SUSPECTED STRIPS, WITH A 2-YEAR SHELF LIFE, WERE MANUFACTURED ON 2025-06-12. THEY WERE RE-TESTED USING THE SUSPECTED METERS WITH VALID GLUCOSE CONTROL SOLUTIONS (LEVEL LOW BATCH NO.: 4AH1A07, EXP. 2026-10-31; LEVEL HIGH BATCH NO.: 4AH3A23, EXP. 2026-07-31). THE GCS TEST RESULTS (LEVEL LOW: 62 / 57; LEVEL HIGH: 289 / 273) MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 28-68; LEVEL HIGH: 223-323). IN ADDITION, THE DESICCANTS IN BOTH STRIP VIALS REMAINED FUNCTIONAL (ORANGE COLOR). 4.BASED ON THE ABOVE RESULTS, NO NONCONFORMANCE OR MALFUNCTION OF THE SUSPECTED ITEMS WAS IDENTIFIED. THE ROOT CAUSE OF THE COMPLAINT COULD NOT BE VERIFIED DUE TO INSUFFICIENT CRITICAL INFORMATION. THEREFORE, THE COMPLAINT WILL BE CLOSED IF NO FURTHER INFORMATION OR ACTION IS PROVIDED BY THE USER.

    Description of Event or Problem · 0

    CALLER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2025 AROUND 6:00 PM AT HOME. CALLER STATED THAT THE END-USER TESTED THEIR BLOOD GLUCOSE WITH THE PRODIGY METER AND RECEIVED A READING OF 400MG/DL. CALLER STATED THAT THEY DID NOT EAT OR DRINK PRIOR TO TESTING. CALLER ALSO STATED THAT THEY DID NOT PERFORM ANY ADDITIONAL TESTS. CALLER DID NOT PROVIDE THE NORMAL READING SHE WOULD USUALLY GET FOR THAT TIME OF DAY. CALLER STATED THAT THE PARAMEDICS WERE NOT CALLED. CALLER STATED THAT THE END-USER WAS DRIVEN TO (B)(6) MEDICAL CENTER LOCATED AT (B)(6). CALLER STATED THAT THE END-USERS BLOOD GLUCOSE WHEN SHE ARRIVED AT THE HOSPITAL WAS 154MG/DL. CALLER STATED THAT THERE WAS NO TREATMENT PROVIDED AT THE ER. CALLER STATED THAT THE END-USER WAS AT THE HOSPITAL FOR ABOUT FIVE HOURS AND WHEN DISCHARGED HER BLOOD GLUCOSE WAS 115MG/DL. CALLER DECLINED TO PROVIDE ANY MEDICATION SHE CURRENTLY TAKES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307814 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Hospitalization DECLINED TO PROVIDE.