BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 18441974 · Received January 4, 2024

    Report

    Report Number
    3005862821-2024-00002
    Event Type
    Injury
    Date Received
    January 4, 2024
    Date of Event
    December 6, 2023
    Report Date
    December 29, 2023
    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)(4)) AFTER OKB REVIEWED DEVICE HISTORY RECORD (DHF) OF THE SUSPECTED METER (SERIAL#: (B)(6)) AND STRIPS (LOT#: D220725B-1). 2. THE METER WAS SHIPPED TO PDC ON 2022-06-27, AND STRIPS WITH 2-YEAR SHELF LIFE WERE MANUFACTURED ON 2022-07-25. BECAUSE THE SUSPECTED ITEMS WERE 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: 2AH1A04 AND EXP. BY 2025-01-31; BATCH# OF LEVEL HIGH: 2AH3A19 AND EXP. BY 2025-01-31). GCS TEST RESULTS (LEVEL LOW: 60/62; LEVEL HIGH: 321/310) MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 30~75; LEVEL HIGH: 230~340). 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 SHE SOUGHT MEDICAL ATTENTION ON (B)(6) 2023 AROUND 4:00PM AT HOME. CALLER STATED THAT THE METER GAVE THE END-USER A HIGHER THAN NORMAL GLUCOSE RESULT. THE CALLER DECLINED TO ANSWER ANY QUESTIONS IN REGARDS TO THE MEDICAL EVENT. CALLER ONLY STATED THAT THE END-USER WENT TO THE HOSPITAL DUE TO HER READING FROM HER PRODIGY METER. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615005 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D220725B-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Female Required Intervention DECLINED TO PROVIDE.