BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 18280941 · Received December 7, 2023

    Report

    Report Number
    3005862821-2023-00014
    Event Type
    Injury
    Date Received
    December 7, 2023
    Date of Event
    November 7, 2023
    Report Date
    November 28, 2023
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    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#: D171229-2). 2.THE SUSPECTED METER THAT WAS SHIPPED TO PDC ON 2017-03-16 WAS USED TO RE-EXAMINE ITS SETTING AND ALL FUNCTIONS, AND NO MALFUNCTION OCCURRED. STANDBY CURRENT (1.5 UA) OF THE SUSPECTED ONE MET ACCEPTANCE CRITERIA (< 55 UA). 3. SUSPECTED STRIPS WITH 2-YEAR SHELF LIFE WERE MANUFACTURED ON 2017-12-29. 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: 66/66; LEVEL HIGH: 333/337) MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 40~85; 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 11/07/2023 AROUND 8:19PM AT HOME. CALLER STATED THAT THE END-USER TESTED HIS BLOOD GLUCOSE WITH HIS PRODIGY METER AND RECEIVED A RESULT OF 301MG/DL. CALL IS UNSURE WHAT A NORMAL RESULT IS FOR THE END-USER FOR THAT TIME OF DAY. CALLER STATED THAT SHE CALLED THE END-USERS DOCTOR AND WAS TOLD TO GO TO THE EMERGENCY ROOM TO BE TESTED. CALLER STATED THAT THE END-USER DID NOT HAVE ANY SYMPTOMS THAT THEY WENT TO THE HOSPITAL DUE TO THE DR TELLING THEM TO. THERE WAS NO FOOD DRINK OR MEDIATION CONSUMED PRIOR TO GOING TO (B)(6) HOSPITAL LOCATED AT (B)(6). THE CALLER STATED THAT THE END-USER HAD HIS BLOOD GLUCOSE TESTED AND RECEIVED A RESULT OF 97MG/DL. THERE WAS NO TREATMENT RECEIVED AND THE END-USER WAS DISCHARGED. THE CALLER STATED THAT THE TEST STRIPS THAT THE END-USER HAD WERE EXPIRED. CALLER WAS EDUCATED TO NEVER USE EXPIRED PRODUCT AND TO DISCARD ANY TEST STRIPS THAT ARE OUT OF DATE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877461 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D171229-2

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male ASPIRIN| ATENOLOL| ATORVASTATIN| B12| B3| EPINEPHRINE| GLIMEPIRIDE| OZEMPIC| TAMSULOSIN