BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 17639733 · Received August 29, 2023

    Report

    Report Number
    3005862821-2023-00011
    Event Type
    Injury
    Date Received
    August 29, 2023
    Date of Event
    July 24, 2023
    Report Date
    August 17, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    1. NO NONCONFORMANCE WAS FOUND AND RECORDED IN THE DOCUMENT ((B)(6)) AFTER OKB REVIEWED DEVICE HISTORY RECORD (DHF) OF THE SUSPECTED METER (SERIAL#: (B)(6)) AND STRIPS (LOT#: D160722-1). 2. THE METER WAS SHIPPED TO PDC ON (B)(6) 2021, AND STRIPS WITH 2-YEAR SHELF LIFE WERE MANUFACTURED ON (B)(6) 2016. BECAUSE THE SUSPECTED ITEMS WERE NOT RETURNED TO OKB, THE RETAINED METER (SERIAL#: (B)(6)) WAS USED TO RE-EXAMINE ITS SETTING AND ALL FUNCTIONS, AND NO MALFUNCTION OCCURRED. ALSO, STRIPS WERE EXPIRED AND OUT OF SPECIFICATIONS. THE RETAINED METER WAS RE-TESTED BY ANY RETAINED STRIPS (LOT#: D230320B-4) FROM OKB'S WAREHOUSE AND 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). GCS TEST RESULTS (LEVEL LOW: 68/60; LEVEL HIGH: 305/306) MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 40~85; LEVEL HIGH: 230~340). 3. ALTHOUGH THE RETAINED METER OPERATED PROPERLY, 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 HE SOUGHT MEDICAL ATTENTION ON (B)(6) 2023 AROUND 8:00M AT HOME. CALLER STATED THAT THE END-USER TESTED HER BLOOD GLUCOSE WITH HER PRODIGY METER AND RECEIVED A RESULT OF 400MG/DL. CALLER DID NOT KNOW WHAT THE END-USERS NORMAL RANGE IS FOR THAT TIME OF DAY. CALLER STATED THAT THE END-USER WAS ALARMED AT THE HIGH RESULT AND HAD HER HOME NURSE TAKE HER TO THE (B)(6) EMERGENCY CENTER - (B)(6) HOSPITAL, ROYAL OAK LOCATED AT (B)(6). CALLER STATED THAT THE END-USER TOLD HER THAT SHE DID NOT CONSUME ANY FOOD DRINK OR MEDICATION PRIOR TO GOING TO THE HOSPITAL. CALLER STATED THAT WHEN THE END-USER ARRIVED AT THE HOSPITAL THE END-USERS BLOOD GLUCOSE WAS IN THE 100S (SHE WAS UNSURE OF THE EXACT NUMBER). CALLER STATED THAT THE END-USER WAS NOT TREATED FOR ANYTHING WHILE AT THE HOSPITAL. CALLER DOES NOT KNOW WHAT THE END-USER BLOOD GLUCOSE WAS WHEN SHE WAS DISCHARGED FROM THE HOSPITAL. THE END-USER WAS USING EXPIRED TEST STRIPS. CALLER WAS EDUCATED THAT EXPIRED TEST STRIPS SHOULD BE DISCARDED AND A NEW VIAL OPENED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999656 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D160722-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female ASPIRIN| DOCUSATE| FLUOXETINE| LEVOTHYROXINE| LIDOCAINE| LORAZEPAM| MAGNESIUM OXIDE| METHOCARBAMOL| METOPROLOL| OLANZAPINE| OXYBUTYNIN| POLYETHYLENE GLYCOL| PRAVASTATIN| SENNA