BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 12622091 · Received October 13, 2021

    Report

    Report Number
    3005862821-2021-00018
    Event Type
    Injury
    Date Received
    October 13, 2021
    Date of Event
    September 13, 2021
    Report Date
    September 20, 2021
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841518505
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO NONCONFORMANCE WAS FOUND AND RECORDED IN THE DOCUMENT ((B)(4)) AFTER OKB REVIEWED DEVICE HISTORY RECORD (DHF) OF THE SUSPECTED METER (SERIAL#: (B)(4)) AND STRIPS (LOT#: D190729-1). THE METER WAS SHIPPED TO PDC ON (B)(6) 2019, AND STRIPS WITH 2-YEAR SHELF LIFE WERE MANUFACTURED ON 2019-07-29. BECAUSE THE SUSPECTED ITEMS WERE NOT RETURNED TO OKB, THE RETAINED METER (SERIAL#: (B)(4)) 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#: D210611B-1) FROM OKB'S WAREHOUSE AND ANY VALID CONTROL SOLUTIONS (BATCH# OF LEVEL LOW: 9AH1A02 AND EXP. BY 2022-02-28; BATCH# OF LEVEL HIGH: 0AH3A17 AND EXP. BY 2022-12-31). RE-TESTING RESULTS AS BELOW MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 30~75 ; LEVEL HIGH: 230~340), AND DESICCANTS OF THE STRIP VIAL ARE FUNCTIONAL (ORANGE COLOR). RETAINED METER W/ ANY RETAINED STRIPS: 51/46 (LEVEL LOW) AND 305/303 (LEVEL HIGH). ALTHOUGH THE RETAINED METER OPERATED PROPERLY, EXPIRED STRIPS MAY CAUSE INACCURATE BLOOD GLUCOSE READINGS ACCORDING TO USER'S STATEMENT RECORDED ON FDA FORM 3500A. 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 · 1

    CALLER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2021 AROUND 6:30AM AT HOME. CALLER STATED THAT THEY TESTED THE END-USERS BLOOD GLUCOSE WITH THEIR PRODIGY METER AND RECEIVED A RESULT OF 350MG/DL. A NORMAL RESULT FOR THIS TIME OF DAY IS USUALLY AROUND 150MG/L. THE CALLER STATED THAT THE END-USER WAS NOT ABLE TO ASSIST WITH TESTING HER BLOOD GLUCOSE AND WAS NOT RESPONSIVE SO PARAMEDICS WERE CALLED IMMEDIATELY. THERE WAS NO FOOD DRINK OR MEDICATION CONSUMED WHILE WAITING FOR PARAMEDICS TO ARRIVE. PARAMEDICS ARRIVED WITHIN 10 MINUTES AND TESTED THE END-USERS BLOOD GLUCOSE WITH THEIR METER AND RECEIVED A RESULT OF 22MG/DL. THE PARAMEDICS ADMINISTERED A GLUCOSE IV AND TRANSPORTED THE END-USER TO (B)(6) HOSPITAL LOCATED AT (B)(6). THE CALLER DOES NOT RECALL WHAT THE END-USERS BLOOD GLUCOSE WAS WHEN SHE ARRIVED AT THE HOSPITAL. THE HOSPITAL CHECKED THE END-USERS BLOOD AND OXYGEN AND THE END-USER WAS DISCHARGED AFTER 3 HOURS WITH A BLOOD GLUCOSE OF 150MG/DL. THE END-USER WAS USING EXPIRED TEST STRIPS AND WAS EDUCATED TO NEVER USE EXPIRED PRODUCTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1519942 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D190729-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization