BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 9719436 · Received February 18, 2020

    Report

    Report Number
    3005862821-2020-00008
    Event Type
    Injury
    Date Received
    February 18, 2020
    Date of Event
    January 15, 2020
    Report Date
    January 22, 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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE DEVICE AND STRIPS WERE NOT RETURNED TO OK BIOTECH, THEREFORE, WE WERE UNABLE TO PERFORM FURTHER TESTING ON THE SUSPECTED DEVICE. OKB REVIEWED ALL MANUFACTURING AND QC RECORDS OF SUSPECTED METER (SERIAL#: (B)(4)) AND STRIPS (LOT#: D181031-2), AND NO NON-CONFORMITY WERE FOUND. THE METER WAS SHIPPED TO PDC ON JULY 05, 2017. THE STRIPS (LOT#: D181031-2) WERE MANUFACTURED ON 10/31/2018 AND WILL EXPIRE ON OCT. 31, 2020. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS. WE TESTED THE RETAINED STRIPS(LOT#: D181031-2) FROM OUR WAREHOUSE WITH OUR IN-HOUSE METER (SERIAL#: (B)(4)) AND CONTROL SOLUTION (LEVEL LOW: BATCH# 8AH1A94, EXP. BY DEC., 2020; LEVEL HIGH: BATCH# 8AH3A14, EXP. BY SEPT., 2020). AND RESULTS ARE LEVEL LOW: 66/63 MG/DL; LEVEL HIGH: 236/245 MG/DL, ALL RESULTS MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 35~85; LEVEL HIGH: 210~320). ACCORDING TO PDC'S COMPLIANT RECORD, THE DESICCANT COLOR IN PATIENT'S STRIPS WERE CHANGED TO GREEN COLOR INDICATED STRIPS MIGHT GET MOISTURE. PATIENT USED THOSE STRIPS TO TEST BLOOD MIGHT CAUSED OR CONTRIBUTED TO HIGHER READINGS. USER STORAGE OR OPERATION ISSUE.

    Description of Event or Problem · 1

    CALLER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2020 AROUND 9:00PM AT HOME. CALLER STATED THAT THE END-USER TESTED HER BLOOD GLUCOSE AND RECEIVED A RESULT OF 200MG/DL. CALLER SAID THE END-USER'S NORMAL RANGE FOR THAT TIME OF DAY IS USUALLY AROUND 100MG/DL. CALLER STATED THAT THE END-USER TOOK HER DAILY MORNING MEDICATIONS BUT DID NOT SPECIFY WHAT THOSE WERE. AFTER ABOUT 45 MINUTES OF GETTING THE RESULT OF 200 MG/DL EMS WERE CALLED. CALLER STATED THAT THE END-USER HAD A HEADACHE. EMS ARRIVED IN ABOUT 10 MINUTES AND TESTED THE END-USER WITH THEIR METER AND GOT A RESULT OF 135MG/DL. END-USER WAS NOT TRANSPORTED TO THE HOSPITAL AND THE EMS DID NOT PROVIDE ANY SORT OF TREATMENT. PRIOR TO THE EMS LEAVING THE TESTED HER BLOOD GLUCOSE AGAIN WITH THEIR METER AND GOT A RESULT OF 121MG/DL . NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184084 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D181031-2 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR