BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 17313540 · Received July 12, 2023

    Report

    Report Number
    3005862821-2023-00006
    Event Type
    Injury
    Date Received
    July 12, 2023
    Date of Event
    June 23, 2023
    Report Date
    July 7, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    1.NO NONCONFORMANCE WAS FOUND AND RECORDED IN THE DOCUMENT (QA-W-21-03) AFTER OKB REVIEWED DEVICE HISTORY RECORD (DHF) OF THE SUSPECTED METER (SERIAL#: (B)(6) AND STRIPS (LOT#: D171124-1). 2.THE SUSPECTED METER THAT WAS SHIPPED TO PDC ON 2021-07-28 WAS USED TO RE-EXAMINE ITS SETTING AND ALL FUNCTIONS, AND NO MALFUNCTION OCCURRED. STANDBY CURRENT (3.4 UA) OF THE SUSPECTED ONE MET ACCEPTANCE CRITERIA (< 55 UA). 3.SUSPECTED STRIPS WITH 2-YEAR SHELF LIFE WERE MANUFACTURED ON 2017-11-24. BECAUSE THEY WERE EXPIRED AND OUT OF SPECIFICATIONS, THE SUSPECTED METER WAS TESTED BY USING ANY RETAINED STRIPS (LOT#: D230320B-4) 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: 67/69; LEVEL HIGH: 330/334) MET THE ACCEPTANCE CRITERIA (LEVEL LOW GCS RANGE: 40~85; LEVEL HIGH GCS RANGE: 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 7:30PM AT HOME. CALLER STATED THAT HE TESTED HIS BLOOD GLUCOSE WITH HIS PRODIGY METER AND HE RECEIVED A RESULT OF 137MG/DL. CALLER STATED THAT HE TOOK 10 UNITS OF HUMALOG. A NORMAL RESULT FOR THAT TIME OF DAY IS USUALLY AROUND 200MG/DL. CALLER STATED THAT AFTER AN UNDETERMINED AMOUNT OF TIME HE STARTED SWEATING AND FELT UNWELL SO HE ATE A SWEET ROLL AND DRANK A GINGER ALE. CALLER THEN SAID HE TESTED HIS BLOOD GLUCOSE AGAIN WITH HIS PRODIGY METER TWICE AND HE RECEIVED A RESULT OF 161MG/DL AND 201MG/DL. CALLER STATED THAT HE PASSED OUT. CALLER STATED THAT HIS FRIEND THEN CALLED PARAMEDICS. CALLER STATED THAT HE WOKE UP IN AN AMBULANCE DUE TO THE PARAMEDICS ADMINISTERING GLUCOSE THROUGH AN IV. CALLER STATED HE WAS INFORMED THE PARAMEDICS PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND RECEIVED A RESULT OF 137MG/DL. END-USER WAS NOT TRANSPORTED TO THE HOSPITAL. CALLER STATED THAT HIS FRIEND MADE HIM TWO JELLY SANDWICHES AS HE WAITED IN THE AMBULANCE. CALLER STATED THAT THE PARAMEDICS THEN TESTED HIS BLOOD GLUCOSE AGAIN WITH THEIR METER AND RECEIVED A RESULT OF 289MG/DL. THE PARAMEDICS THEN RELEASED THE CALLER. CALLER WAS INFORMED THAT THE TEST STRIPS HE WAS USING WERE EXPIRED. CALLER WAS EDUCATED NOT TO USE ANY EXPIRED PRODUCTS AND TO DISCARD THEM. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313929 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D171124-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention BABY ASPIRIN.| HUMALOG.| HUMALOG.| LANTUS.| PROGRAF.