BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 10682252 · Received October 15, 2020

    Report

    Report Number
    3005862821-2020-00054
    Event Type
    Injury
    Date Received
    October 15, 2020
    Date of Event
    August 1, 2020
    Report Date
    September 11, 2020
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841518505
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO NON-CONFORMITY WAS FOUND AFTER OKB REVIEWED ALL MANUFACTURING AND QC RECORDS OF THE SUSPECTED METER (SERIAL#: (B)(4)) AND STRIPS (LOT#: D171226-1). THE METER WAS SHIPPED TO PDC ON 04/16/2019. STRIPS WERE MANUFACTURED ON 12/26/2017, AND WERE EXPIRED IN 12/2019. BECAUSE THE SUSPECTED BGMS WAS NOT RETURNED TO OKB, THE RETAINED DEVICE (SERIAL#: (B)(4)) WAS USED TO RE-TEST, AND THE COMPLAINT SITUATIONS DID NOT OCCUR. ALSO, THE SUSPECTED STRIPS WERE EXPIRED AND OUT OF SPECIFICATIONS. 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 · 1

    CALLER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2020 AROUND 8:30PM AT HOME. CALLER STATED THAT THE END-USERS BLOOD GLUCOSE WAS CHECKED WITH HIS PRODIGY METER, AND THEY RECEIVED A RESULT OF 518MG/DL. CALLER STATED THAT A NORMAL RESULT FOR THE END-USER FOR THAT TIME OF DAY IS USUALLY AROUND 88-114MG/DL. THE CALLER STATED THAT HE TESTED THE END-USER FOUR MORE TIMES AND RECEIVED RESULTS OF 518MG/DL, 300MG/DL, 400MG/DL, 298MG/DL. THE END-USER WAS USING EXPIRED TEST STRIPS, THE CALLER WAS ADVISED TO NEVER USE EXPIRED PRODUCTS. CALLER STATED THAT THE END-USER DID NOT HAVE ANY SYMPTOMS, BUT HE STILL CALLED PARAMEDICS ABOUT 10MINUTES AFTER TESTING. THERE WERE NO FOOD DRINK OR MEDICATIONS CONSUMED WHILE WAITING FOR THE PARAMEDICS TO ARRIVE. PARAMEDICS ARRIVED IN ABOUT 5 MINUTES AND TESTED THE END-USER WITH THEIR METER AND RECEIVED A RESULT OF 147OR 157MG/DL. CALLER STATED THAT THE PARAMEDICS DID NOT HAVE ANY TEST STRIPS, SO THEY USED ONE OF THE END-USERS EXPIRED PRODIGY TEST STRIPS. THE CALLER WAS INFORMED THAT PRODIGY TEST STRIP ARE ONLY FOR PRODIGY METERS AND MAY NOT GIVE AN ACCURATE RESULT WHEN USED WITH ANOTHER METER. CALLER DID NOT WANT TO PROVIDE THE LIST OF MEDICATIONS THAT THE END-USER IS CURRENTLY PRESCRIBED. HE ALSO STATED THAT HE WAS UNABLE TO POWER THE METER ON TO GIVE US THE METER MEMORY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1151723 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D171226-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR