BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 9231514 · Received October 24, 2019

    Report

    Report Number
    3005862821-2019-00056
    Event Type
    Injury
    Date Received
    October 24, 2019
    Date of Event
    September 13, 2019
    Report Date
    September 26, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT ONLY RETURNED HER STRIPS, BUT DEVICE NOT RETURNED. 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 04/20/2017. WE TESTED THE RETURNED STRIPS (STRIP LOT NUMBER: D181031-2 ) WITH OUR IN HOUSE CONTROL SOLUTION AND METER. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 90/78 MG/DL, FOR LEVEL HIGH WERE 243/256 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~85 MG/DL; LEVEL HIGH 210~320 MG/DL. ONE RESULT WAS OUT OF THE ACCEPTANCE RANGE. ALSO WE FOUND THE DESICCANT COLOR INSIDE THE BOTTLE HAD CHANGED, INDICATE THE STRIPS MIGHT GET MOISTURE. WE TEST OUR RETAIN STRIPS FROM OUR WAREHOUSE (STRIP LOT NUMBER: D181031-2 ) WITH OUR IN HOUSE CONTROL SOLUTION AND METER. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 63/66 MG/DL; FOR LEVEL HIGH WERE 238/245 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 . BECAUSE THE DESICCANT COLOR CHANGED FROM PATIENT'S STRIPS, INDICATE THE 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

    REPORTER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AROUND 10:00AM AT THE END-USER'S HOME. END-USER STATED SHE TOOK HER MORNING MEDICATIONS AROUND 7:30AM ATE A BREAKFAST OF COFFEE, BACON, SCRAMBLED EGGS. SHE SAID SHE STARTED TO FEEL AS THOUGH HER BLOOD GLUCOSE WAS LOW. SHE TESTED WITH HER PRODIGY METER AND RECEIVED A RESULT S OF 172MG/DL, SHE THEN TESTED AGAIN AND GOT A RESULT OF 190MG/DL, A NORMAL RESULT FOR HER IS AROUND 160-170MG/DL. ABOUT 30 MINUTES AFTER TESTING WITH HER PRODIGY METER SHE STARTED TO FEEL AS THOUGH HER MOUTH WAS NUMB AND SHE WAS EXPERIENCING DIZZINESS, SO SHE CALLED PARAMEDICS. SHE DID NOT EAT OR TAKE ANY MEDICATION WHILE WAITING FOR THE PARAMEDICS TO ARRIVE. PARAMEDICS ARRIVED WITHIN 10-15 MINUTES AND TESTED HER BLOOD GLUCOSE WITH THEIR METER AND RECEIVED A RESULT OF 48MG/DL. PARAMEDICS DID NOT TEST HER WITH HER PRODIGY METER. PARAMEDICS DID NOT GIVE HER ANY SORT OF TREATMENT. SHE WAS THEN TRANSPORTED TO THE HOSPITAL BY THE PARAMEDICS. END-USER STATED SHE DOES NOT RECALL WHAT HER BLOOD GLUCOSE WAS UPON ARRIVING AT THE HOSPITAL. END-USER STATED SHE HAD A CAT SCAN LUNG X-RAY AND EKG AND ALL RESULTS WERE NORMAL. SHE STATED THE HOSPITAL GAVE HER GLUCOSE SOLUTION THROUGH IV. SHE STATED SHE WAS ADMITTED FOR 25 HOURS AND THEN DISCHARGED WITH INSTRUCTIONS TO FOLLOW UP WITH HER PRIMARY DOCTOR. HER PRIMARY DOCTOR CHANGED HER NOVOLOG FROM 15 UNITS TO 8 UNITS AND HER LEVEMIR FROM 26 UNITS TO 22 UNITS. END-USER WAS UNABLE TO PROVIDE A LIST OF HER MEDICATIONS OTHER THAN HER INSULIN. THE END-USER WAS TREATED AT (B)(6) HEALTH SYSTEM LOCATED AT (B)(6). NO ADDITIONAL DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1025466 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D181031-2 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization