BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 16394422 · Received February 17, 2023

    Report

    Report Number
    3005862821-2023-00003
    Event Type
    Injury
    Date Received
    February 17, 2023
    Date of Event
    January 2, 2023
    Report Date
    February 10, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    1. NO NONCONFORMANCE WAS FOUND IN THE DOCUMENT (QA-W-21-03) AFTER OKB REVIEWED DEVICE HISTORY RECORD (DHF) OF THE SUSPECTED METER (SERIAL#: (B)(4)) AND STRIPS (LOT#: D170620-2). 2. THE SUSPECTED METER SHIPPED TO PDC ON 2017-02-23 AND RETURNED TO OKB ON FEB. 15, 2023. WE TESTED THE RETURNED METER ON ALL SETTING AND FUNCTIONS, AND NO MALFUNCTION WAS FOUND. STANDBY CURRENT OF THE RETURNED METER (1.7 UA) MET ACCEPTANCE CRITERIA (< 55 UA). 3. SUSPECTED STRIPS WITH 2-YEAR SHELF LIFE WERE MANUFACTURED ON 2017-02-23. BECAUSE THEY WERE EXPIRED AND OUT OF SPECIFICATIONS, THE SUSPECTED METER WAS TESTED BY USING ANY RETAINED STRIPS (LOT#: D210611B-1) FROM OKB'S WAREHOUSE AND 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: 60/63; LEVEL HIGH: 297/292) MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 30~75; LEVEL HIGH: 230~340). 4. EXPIRED STRIPS MAY CAUSE INACCURATE BLOOD GLUCOSE READINGS. WARNING INFORMATION REGARDING NOT TO USE EXPIRED STRIPS WAS DISCLOSED IN USER'S MANUAL AND STRIP LABELING TO AVOID THIS PROBLEM. FURTHERMORE, THE EXPIRATION DATE WAS SHOWN CLEARLY ON THE STRIP LABEL, STRIP BOX AND KIT BOX. THEREFORE, THE ROOT CAUSE OF THE COMPLAINT RESULTED FROM USER'S IMPROPER OPERATION.

    Description of Event or Problem · 0

    CALLER STATED THAT SHE SOUGHT MEDICAL ATTENTION ON (B)(6) 2023 AROUND 3:30PM AT HOME. CALLER STATED THAT SHE TESTED HER BLOOD GLUCOSE WITH HER PRODIGY METER AND RECEIVED A RESULT OF 365MG/DL. A NORMAL RESULT FOR THAT TIME OF DAY IS USUALLY AROUND 110-119MG/DL. CALLER STATED THAT SHE THEN TESTED HER BLOOD GLUCOSE THREE MORE TIMES WITH HER PRODIGY METER AND RECEIVED RESULTS OF 303MG/DL, 360MG/DL, AND 362MG/DL. CALLER STATED THAT SHE DID NOT CONSUME ANY MEDICATION FOOD OR DRINK PRIOR OR AFTER TESTING. CALLER STATED THAT SHE TOOK HER MORNING MEDICATIONS AT 7:00AM. SHE HAD A BREAKFAST OF CHEERIOS AND TUNA SANDWICH FOR LUNCH. CALLER STATED SHE DID NOT HAVE SYMPTOMS BUT SHE HAS HER HUSBAND DRIVER HER TO (B)(6). CALLER STAT THAT WHEN SHE ARRIVED AT THE HOSPITAL HER BLOOD GLUCOSE WAS 120MG/DL. CALLER STATED THAT SHE RECEIVED NO TREATMENT EXCEPT HAVING HER BLOOD GLUCOSE CHECKED. CALLER WAS INFORMED SHE WAS USING EXPIRED PRODIGY TEST STRIPS, SHE WAS EDUCATED TO NEVER USE EXPIRED PRODUCT AND TO DISCARD THEM AND OPEN A NEW VIAL. CALLER STATED THAT TWICE THE DOCTOR AT THE HOSPITAL CHECKED HER BLOOD GLUCOSE AND THE RESULTS WERE 116MG/DL 99MG/DL. SHE STATED THAT WHEN SHE WAS DISCHARGED HER BLOOD GLUCOSE WAS 120MG/DL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116903 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D170620-2 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female GLIPIZIDE.| METOPROLOL.| ROPINIROLE.