BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 16190963 · Received January 17, 2023

    Report

    Report Number
    3005862821-2023-00001
    Event Type
    Injury
    Date Received
    January 17, 2023
    Date of Event
    December 24, 2022
    Report Date
    January 12, 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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    1. NO NONCONFORMANCE WAS FOUND IN THE DOCUMENT ((B)(4)) AFTER OKB REVIEWED DEVICE HISTORY RECORD (DHF) OF THE SUSPECTED METER (SERIAL#: (B)(4). AND STRIPS (LOT#: D211028B-1). 2. THE SUSPECTED METER SHIPPED TO PDC ON 2017-07-05 AND RETURNED TO OKB ON JAN. 13, 2023. WE TESTED THE RETURNED METER ON ALL SETTING AND FUNCTIONS, AND NO MALFUNCTION WAS FOUND. STANDBY CURRENT OF THE RETURNED METER (1.3 UA) MET ACCEPTANCE CRITERIA (< 55 UA). 3. SUSPECTED STRIPS WITH 2-YEAR SHELF LIFE WERE MANUFACTURED ON 2021-10-28 AND WILL EXPIRY IN OCT. 2023. WE TESTED THE SUSPECTED STRIPS (LOT#D210127-1) BY SUSPECTED METER WITH ANY VALID CONTROL SOLUTIONS WITH US (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: 53/64; LEVEL HIGH: 303/297) MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 30~75; LEVEL HIGH: 220~340). 4. AS ABOVE, NO NON-CONFORMANCE AND MALFUNCTION OF THE SUSPECTED ITEMS WERE FOUND. THE ROOT CAUSE OF THE COMPLAINT WAS UNABLE TO BE VERIFIED WITHOUT MORE CRITICAL INFORMATION. THEREFORE, THE COMPLAINT HAS TO BE CLOSED OUT IF NO FURTHER ACTION AND INFORMATION FROM THE USER.

    Description of Event or Problem · 0

    CALLER STATED THAT SHE SOUGHT MEDICAL ATTENTION ON (B)(6) 2022 AROUND 12:00AM AT HOME. END-USER STATED THAT SHE TESTED HER BLOOD GLUCOSE WITH HER PRODIGY METER AND RECEIVED A RESULT OF HI. A NORMAL RESULT FOR THAT TIME OF DAY IS USUALLY AROUND 120MG/DL. ABOUT AN HOUR AFTER TESTING WITH THE PRODIGY METER, THE END-USER BECAME UNCONSCIOUS AND STARTED FOAMING AT THE MOUTH, AND PARAMEDICS WERE CALLED. THERE WAS NO FOOD, DRINK OR MEDICATION WAS CONSUMED WHILE WAITING FOR PARAMEDICS TO ARRIVE. PARAMEDICS ARRIVED WITHIN MINUTES, TESTED THE END-USERS BLOOD GLUCOSE WITH THEIR METER, AND RECEIVED A RESULT OF 20MG/DL. PARAMEDICS GAVE THE END-USER GLUCAGON AND TRANSPORTED HER TO (B)(6) HOSPITAL LOCATED AT (B)(6). THE END-USER ARRIVED AT THE HOSPITAL WITH A BLOOD GLUCOSE OF 20MG/DL. END-USER STATED THAT SHE RECEIVED ANOTHER SHOT OF GLUCAGON AT THE HOSPITAL AND WAS THERE FOR APPROXIMATELY 4-5 HOURS. THE END USER WAS DISCHARGED AND TOLD TO FOLLOW UP WITH HER PRIMARY DOCTOR. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1587 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D211028B-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Hospitalization HUMALOG| HUMULIN| INSULIN| LEVOXYL| PRAVASTATIN