BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 24517080 · Received March 5, 2026

    Report

    Report Number
    3005862821-2026-00002
    Event Type
    Malfunction
    Date Received
    March 5, 2026
    Date of Event
    January 20, 2026
    Report Date
    February 18, 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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    1. NO NONCONFORMANCE WAS FOUND AND RECORDED IN THE DOCUMENT ((B)(6)) AFTER OKB REVIEWED DEVICE HISTORY RECORD (DHF) OF THE SUSPECTED METER (SERIAL#: (B)(6)) AND STRIPS (LOT#: D250721A-4). 2. THE METER WAS SHIPPED TO PDC ON (B)(6) 2025, AND STRIPS WITH 2-YEAR SHELF LIFE WERE MANUFACTURED ON 2025-07-21. BECAUSE THE SUSPECTED ITEMS WAS NOT RETURNED TO OKB, THE RETAINED METER (SERIAL#: (B)(6)) WAS USED TO RE-EXAMINE ITS SETTING AND ALL FUNCTIONS, AND NO MALFUNCTION OCCURRED. ALSO, RETAINED STRIPS THAT WERE THE SAME BATCH AS SUSPECTED ONES WERE OBTAINED FROM OKB'S WAREHOUSE, AND THEY WERE USED TO RE-TEST BY THE RETAINED METER AND ANY VALID CONTROL SOLUTIONS (BATCH# OF LEVEL LOW: 4AH1A07 AND EXP. BY 2026-10-31; BATCH# OF LEVEL HIGH: 4AH3A23 AND EXP. BY 2026-07-21). GCS TEST RESULTS (LEVEL LOW: 45/47; LEVEL HIGH: 293/310) MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 28~68; LEVEL HIGH: 223~323). 3. THE ROOT CAUSE OF THE COMPLAINT WAS UNABLE TO BE VERIFIED WITHOUT THE SUSPECTED ITEMS AND MORE CRITICAL INFORMATION. THEREFORE, THE COMPLAINT HAS TO BE CLOSED OUT IF NO FURTHER ACTION OR INFORMATION FROM THE USER.

    Description of Event or Problem · 0

    CALLER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2026 AROUND 4:45 PM AT HOME. CALLER STATED THAT THE END-USER TESTED HER BLOOD GLUCOSE WITH HER PRODIGY METER AND RECEIVED A READING OF 504 MG/DL. CALLER STATED THAT PARAMEDICS WERE CALLED DUE TO THE END-USER NOT BEING COMFORTABLE WITH THE READING. A NORMAL READING FOR THAT TIME OF DAY IS USUALLY AROUND 100-200 MG/DL. CALLER STATED THAT PRIOR TO TAKING HIS BLOOD GLUCOSE THE END-USER TOOK THE FOLLOWING MEDICATIONS: DIAZOLE EYE DROPS, GLUCOSAMINE, METFORMIN, REFRESH EYE DROPS. CALLER STATED THAT THE PARAMEDICS WERE CALLED ABOUT 10 MINUTES AFTER TESTING. CALLER STATED THAT THERE WERE NO FOOD MEDICATION OR DRINKS CONSUMED WHILE WAITING FOR THE PARAMEDICS TO ARRIVE. PARAMEDICS ARRIVED 30 MINUTES AFTER TESTING WITH THE PRODIGY METER. PARAMEDICS TESTED THE END-USERS BLOOD GLUCOSE WITH THEIR METER AND RECEIVED A READING OF 182 MG/DL. CALLER STATED THAT THE END-USERS VITALS WERE CHECKED AND NO FURTHER TREATMENT WAS RECEIVED BY PARAMEDICS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579785 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Other ABILIFY 2ML TABLET.| ASPIRIN 81MG DAILY.| BENZOL PEROXIDE WASH.| CINITAB TABLET ONCE DAILY.| CLINTON GEL 2X DAILY.| CLOPIDOGREL 75 MILLIGRAM.| EYE DROPS 2X DAILY.| GLUCOSAMINE 500MG 3 DAY.| HCI 10MILIGRAM TABLET.| HCTZ 25MG TABLET.| KETOCONAZOLE SHAMPOO.| LATANOPROST EYE DAYS ONE DROP DAILY.| LUBRAFRESH PM ONE DAILY.| METFORMIN HCL 500MILIGRAMS TABLET 2X DAILY.| ORAVASTIN 23MG ONE DAILY.| PROPANTRAZIOLE 20MG TABLET.| REFRESH EYE DROPS.| SETROPRAM HBR 20MILIGRAM.| TRAZADONE 100MG DAILY.