BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 25109769 · Received May 7, 2026

    Report

    Report Number
    3005862821-2026-00003
    Event Type
    Malfunction
    Date Received
    May 7, 2026
    Date of Event
    April 6, 2026
    Report Date
    May 7, 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
    OH, 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 SUSPECTED METER (SERIAL#: (B)(6)) AND STRIPS (LOT#: D250221A-4). 2.THE METER WAS SHIPPED TO PDC ON (B)(6) 2025, AND STRIPS WITH 2-YEAR SHELF LIFE WERE MANUFACTURED ON 2025-02-21. BECAUSE THE SUSPECTED ITEMS WAS NOT RETURNED TO OKB, THE RETAINED METER (SERIAL#: OK-A-QC-01) 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: 5AH1A08 AND EXP. BY 2027-11-30; BATCH# OF LEVEL HIGH: 5AH3A25 AND EXP. BY 2027-10-31). GCS TEST RESULTS (LEVEL LOW: 35/37; LEVEL HIGH: 297/292) 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 THEY SOUGHT MEDICAL ATTENTION (B)(6) 2026 AROUND 10:30PM AT HOME. CALLER STATED THEY TESTED THEIR BLOOD GLUCOSE WITH THEIR PRODIGY METER AND RECEIVED A READING OF 526MG/DL. CALLER'S NORMAL READING FOR THAT TIME OF DAY IS USUALLY 150-200MG/DL. CALLER WAS ONLY ABLE TO PROVIDE 2 PREVIOUS READINGS IN THE PRODIGY METER'S MEMORY DUE TO IT BEING CLEARED RECENTLY. CALLER STATED THEY HAD A BREAKFAST SANDWICH AND THEY TOOK THEIR NORMAL DOSAGE OF NOVOLOG, 6 UNITS PRIOR TO PERFORMING THEIR ORIGINAL BLOOD GLUCOSE TEST. CALLER DID NOT TAKE ANY MEDICATIONS AFTER THEIR RESULT OF 526MG/DL. THEY STATED THEY FELT OFF BALANCE AND THEIR HEART WERE RACING. CALLER DROVE TO (B)(6) EMERGENCY DEPARTMENT LOCATED AT (B)(6) AND DID NOT CALL EMS. THEIR BLOOD GLUCOSE READ 384MG/DL WHEN THEY WERE TESTED AT THE HOSPITAL AND TESTED AGAIN 30 MINUTES LATER WITH THE BLOOD GLUCOSE TEST RESULT OF 359MG/DL. NO MEDICATIONS OR TREATMENT WERE GIVING TO THE CALLER BY THE HOSPITAL. CALLER WAS DISCHARGED APPROXIMATELY 2 HOURS AFTER THEIR INITIAL ARRIVAL WITH THEIR LAST BLOOD GLUCOSE READING BEING THE 359MG/DL. THEIR MEDICATIONS WERE CHANGED DURING THEIR DISCHARGE, INCREASING BOTH THEIR MEDICATIONS, NOVALOG - 6 UNITS 3 TIMES A DAY AND LANTIS - 4 UNITS 1 TIME BEFORE BED TO NOVALOG - 14 UNITS 3 TIMES A DAY AND LANTIS - 14 UNITS 1 TIME BEFORE BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294165 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female LANTIS 4 UNITS.| NOVALOG - 6 UNITS.