BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUOTCODE

    MDR report key: 17432024 · Received August 1, 2023

    Report

    Report Number
    3005862821-2023-00007
    Event Type
    Injury
    Date Received
    August 1, 2023
    Date of Event
    June 15, 2023
    Report Date
    July 13, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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) ). THE METER WAS SHIPPED TO PDC ON 2022-05-09. BECAUSE THE SUSPECTED METER WAS NOT RETURNED TO OKB, THE RETAINED ONE (SERIAL#: (B)(6) ) WAS USED TO RE-EXAMINE ITS SETTING AND ALL FUNCTIONS, AND NO MALFUNCTION OCCURRED. ALSO, IT WAS RE-TESTED BY ANY RETAINED STRIPS (LOT#: D230320B-4) FROM OKB'S WAREHOUSE 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: 65/63; LEVEL HIGH: 326/327) MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 40~85; LEVEL HIGH: 230~340). THE ROOT CAUSE OF THE COMPLAINT WAS UNABLE TO BE VERIFIED WITHOUT THE SUSPECTED METER 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 THE END-USER SOUGHT MEDICAL ATTENTION ON (B)(6) 2023 IN THE MORNING (DID NOT KNOW EXACT TIMEFRAME). CALLER STATED THAT THE END-USER TESTED HIS BLOOD GLUCOSE WITH HIS PRODIGY METER AND RECEIVED A RESULT WITH A DECIMAL (CALLER WAS UNABLE TO RECALL THE RESULT). CALLER STATED THAT THE END-USER SAID HE USUALLY HAS A BLOOD GLUCOSE AROUND 99-101MG/DL. CALLER STATED THAT THE END-USER IS HOMELESS AND DOES NOT HAVE A FIXED ADDRESS, AND WAS FOUND UNCONSCIOUS ON THE SIDE OF ROAD ON (B)(6). CALLER STATED THAT THEY DID NOT KNOW THE READING ON THE PRODIGY METER PRIOR TO SEEKING MEDICAL ATTENTION. CALLER STATED THAT THE END-USER WAS TRANSPORTED TO THE (B)(6) HOSPITAL LOCATED AT (B)(6). CALLER DID NOT KNOW WHAT THE END-USERS BLOOD GLUCOSE WAS WHEN HE ARRIVED AT THE HOSPITAL. THE END-USER WAS UNABLE TO PROVIDE HIS CURRENT MEDICATIONS. CALLER STATED THAT THE END-USER WAS STILL ADMITTED INTO THE HOSPITAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2335836 PRODIGY AUOTCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Hospitalization