BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 20028532 · Received August 22, 2024

    Report

    Report Number
    3005862821-2024-00010
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    May 22, 2024
    Report Date
    June 21, 2024
    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 AND RECORDED IN THE DOCUMENT (B)(4) AFTER OKB REVIEWED DEVICE HISTORY RECORD (DHF) OF THE SUSPECTED/RETURNED METER (SERIAL#: (B)(6) AND STRIPS (LOT#: D230918B-1). 2. THE SUSPECTED METER THAT WAS SHIPPED TO PDC ON 2019-11-05 AND RETURNED BY PDC ON JULY 10,2024. WE TESTED THE RETURNED METER AND OUR RETAINED METER (SERIAL#: (B)(6) TO RE-EXAMINE THEIR SETTING AND ALL FUNCTIONS, AND FOUND NO MALFUNCTION OF BOTH METERS OCCURRED. STANDBY CURRENT (9.7 UA) OF THE SUSPECTED METER MET ACCEPTANCE CRITERIA (< 55 UA). 3. THE SUSPECTED STRIPS WITH 2-YEAR SHELF LIFE WERE MANUFACTURED ON 2023-09-18. WE TESTED THE RETURNED STRIP AND THE SAME BATCH OF RETAINED STRIPS FROM OUR WAREHOUSE, TESTING BY RETURNED METERS WITH 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), THE RETURNED STRIPS READINGS (LEVEL LOW: 200/203; LEVEL HIGH: 429/369) OUT THE ACCEPTABLE RANGE (LEVEL LOW: 40~85; LEVEL HIGH: 230~340). THE RETAINED STRIPS READINGS (LEVEL LOW: 52/51; LEVEL HIGH: 282/289) METS THE ACCEPTABLE RANGE (LEVEL LOW: 40~85; LEVEL HIGH: 230~340). 4. BECAUSE THE DESICCANTS OF OUR RETAINED STRIPS FROM OKB'S WAREHOUSE IS STILL FUNCTIONAL (ORANGE COLOR), AND TESTING RESULTS MET THE CRITERIA. HOWEVER, WE FOUND THE DESICCANTS OF PATIENT'S RETURNED STRIPS WERE INEFFECTIVE (DESICCANT COLOR CHANGED TO GREEN INDICATING THE STRIP MIGHT GET MOISTURE), AND TEST RESULTS ABOVE WERE FAILED. THE HIGHER READINGS WERE OBTAINED BECAUSE OF PATIENT'S STRIPS GET MOISTURE AND PRODUCED HIGHER READINGS. THEREFORE, USER'S IMPROPER OPERATION AND PRESERVATION MOSTLY CAUSED THE MALFUNCTION OF THE DEVICE.

    Description of Event or Problem · 0

    CALLER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON 5-22-2024-AROUND 5:50PM AT HOME. CALLER STATED THAT SHE TESTED HER BLOOD GLUCOSE WITH HER PRODIGY METER AND RECEIVED A READING OF 253MG/DL. A NORMAL RESULT FOR THAT TIME OF DAY IS USUALLY AROUND 95-96 MG/DL. CALLER STATED THAT SHE TESTED HER BLOOD GLUCOSE THREE MORE TIMES AND THE READINGS WERE 247MG/DL, 233 MG/DL AND 228 MG/DL. CALLER STATED THAT SHE THEN WENT TO CARE NOW URGENT CARE LOCATED AT (B)(6) CALLER STATED THAT SHE DID NOT HAVE ANY SYMPTOMS BUT WAS NERVOUS ABOUT THE READINGS BEING SO HIGH. CALLER STATED THAT HER BLOOD GLUCOSE WAS 84MG/DL WHEN SHE ARRIVED AT THE URGENT CARE. CALLER STATED THAT SHE WAS NOT GIVEN ANY TREATMENT FOR HER BLOOD GLUCOSE. SHE STATED THAT SHE WAS AT THE URGENT CARE FOR ABOUT 45 MINUTES TO AN HOUR. CALLER STATED THAT SHE WAS TOLD TO FOLLOW UP WITH HER PRIMARY DOCTOR. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2178826 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D230918B-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female