BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 8863539 · Received August 6, 2019

    Report

    Report Number
    3005862821-2019-00034
    Event Type
    Injury
    Date Received
    August 6, 2019
    Date of Event
    July 1, 2019
    Report Date
    July 11, 2019
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384840518858
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. WE TESTED THE STANDBY CURRENT OF RETURNED METER, THE RESULT WAS 0.9¿A. THE CRITERIA IS <55¿A. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. WE TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND RETURNED STRIPS (STRIP LOT NUMBER: D171117-2, ONLY (B)(4) PCS). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 84/87 MG/DL, FOR LEVEL HIGH WERE 289/279 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 40~90 MG/DL; LEVEL HIGH 220~330 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS. HOWEVER WE FOUND THE DESICCANT INSIDE THE STRIP BOTTLE HAD COLOR CHANGED. WE TESTED THE RETAIN STRIPS FROM OUR WAREHOUSE (STRIP LOT NUMBER: D171117-2). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 65/70 MG/DL; FOR LEVEL HIGH WERE 261/252 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 40~90 MG/DL; LEVEL HIGH 220~330 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

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AROUND 11:00AM. END-USER STATED THAT HE TOOK A BLOOD GLUCOSE TEST AND RECEIVED A RESULT OF 293MG/DL, A NORMAL RESULT FOR THAT TIME OF DAY IS 125MG/DL. HE THEN STATED THAT HE STARTED TO FEEL SHAKY AND CONFUSED. END-USER STATED HE WENT TO THE HOSPITAL ON HIS OWN. THERE WAS NO FOOD DRINK OR MEDICATION TAKEN PRIOR TO GOING TO THE HOSPITAL. HE DOES NOT RECALL WHAT IS BLOOD GLUCOSE WAS WHEN HE ARRIVED. HE DID NOT RECEIVE TREATMENT FOR HIS BLOOD GLUCOSE LEVELS. DOCTORS IN THE EMERGENCY ROOM RAN A CAT SCAN AND BLOOD WORK AND EVERYTHING CAME BACK NORMAL. END-USER STATED HE WAS AT THE HOSPITAL FOR 5 HOURS AND WAS NOT ADMITTED. THE END-USERS SLIDING SCALE IS AS FOLLOWS: HUMALOG: (SLIDING SCALE): 100-199MG/DL 7 1/2 UNITS 200-299MG/DL 15 UNITS 300-399MG/DL 22 1/2 UNITS 400-499MG/DL 30 UNITS. END-USER DOES NOT RECALL WHAT HIS BLOOD GLUCOSE WAS WHEN HE WAS DISCHARGED FROM (B)(6) HOSPITAL LOCATED AT (B)(6). NO ADDITIONAL DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659876 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D171117-2 00384840518858

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization