BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 9096458 · Received September 20, 2019

    Report

    Report Number
    3005862821-2019-00047
    Event Type
    Injury
    Date Received
    September 20, 2019
    Date of Event
    August 13, 2019
    Report Date
    August 23, 2019
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841518505
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE DEVICE WAS NOT RETURNED TO OK BIOTECH, THEREFORE, WE WERE UNABLE TO PERFORM FURTHER TESTING ON THE SUSPECTED DEVICE. OK BIOTECH REVIEWED THE MANUFACTURING RECORD OF THIS SUSPECTED DEVICE (METER SERIAL NUMBER # (B)(4)), AND THE METER WAS QUALIFIED AND RELEASED BY THE QUALITY CONTROL DEPARTMENT AND SHIPPED TO PDC ON 07/05/2017. THE STRIP LOT # D181026-1 WAS MANUFACTURED ON 10/26/2018 AND EXPIRED IN 10/26/2020. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS . WE TESTED THE RETAIN STRIPS OF SAME BATCH STRIPS WITH OUR IN HOUSE METER AND CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 58/55 MG/DL; FOR LEVEL HIGH WERE 230/239 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~85 MG/DL; LEVEL HIGH 210~320 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS. WE ARE UNABLE TO CONFIRM THE COMPLAINT BECAUSE DEVICE WAS NOT RETURNED AND NO FURTHER INFORMATION FROM CUSTOMER HAS BEEN RECEIVED, THIS MATTER HAS TO BE CLOSED OUT WITH UNDETERMINED ROOT CAUSE.

    Description of Event or Problem · 1

    END-USER REPORTED MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AROUND 6PM AT HER HOME. END-USER STATED THAT SHE PERFORMED A BLOOD GLUCOSE TEST WITH HER PRODIGY METER AND RECEIVED A RESULT OF 136 MG/DL. HER HUSBAND THEN DID ANOTHER TEST WHEN HE REALIZED SHE WASN'T RESPONDING AND RECEIVED A RESULT OF 134 MG/DL. END-USER STATED THAT HER HUSBAND CALLED THE PARAMEDICS GAVE HER SOME JUICE AND A DEXTROSE TAB. END-USER WAS UNSURE HOW LONG IT TOOK FOR THE PARAMEDICS TO ARRIVE. UPON THEIR ARRIVAL THEY PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND RECEIVED A RESULT OF 57 MG/DL. PARAMEDICS THEN GAVE HER A PACKET OF GLUCOSE GEL TO RAISE HER BLOOD GLUCOSE. END-USER WAS NOT TRANSPORTED TO THE HOSPITAL BY THE PARAMEDICS AND SHE DID NOT GO ON HER OWN. THE END-USER STATED THAT A NORMAL RESULT FOR HER FOR THAT TIME OF DAY IS AROUND 120 MG/DL, AND SHE TESTS HER BLOOD GLUCOSE 5 TIMES A DAY. SHE IS CURRENTLY PRESCRIBED THE FOLLOWING SLIDING SCALE FOR HER INSULIN: HUMULIN N NPH: 25 UNITS EVERY MORNING HUMULIN R: 150-174 MG/DL 2 UNITS, 175-199 MG/DL 3 UNITS, 200 MG/DL AND OVER 5 UNITS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894498 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D181026-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention