BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6953840 · Received October 16, 2017

    Report

    Report Number
    3005862821-2017-00101
    Event Type
    Injury
    Date Received
    October 16, 2017
    Date of Event
    September 12, 2017
    Report Date
    September 13, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841518505
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 2.7UA. THE CRITERIA IS <55UA. 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:D141211-1 ). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 243/232 MG/DL, FOR LEVEL HIGH WERE 401/449 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~75 MG/DL; LEVEL HIGH 210~310 MG/DL. ALL RESULTS WERE OUT OF THE ACCEPTANCE RANGE. STRIP FROM CUSTOMERS WERE ALL EXPIRED. WE TESTED THE RETURNED METER WITH IN HOUSE STRIPS (STRIP LOT NUMBER:D160526-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 52/54 MG/DL, FOR LEVEL HIGH WERE 246/245 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~80 MG/DL; LEVEL HIGH 190~290 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS. PATIENT USED EXPIRED STRIPS TO TEST HER BLOOD WHICH MIGHT CAUSED OR CONTRIBUTED TO ERROR READINGS. USER ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2017 AT 9:00 AM AFTER THE END USER RECEIVED INCONSISTENT BLOOD GLUCOSE RESULTS FROM HIS PRODIGY DIABETES METER. THE END USER EXPERIENCED SQUINTED EYES AND SHUFFLED FEET. HE WAS TAKEN TO THE ER AND UPON ARRIVAL HIS BLOOD GLUCOSE READING WAS 38 MG/DL. AN IV AND SUGAR WATER WERE ADMINISTERED TO ASSIST IN RAISING HIS BLOOD GLUCOSE LEVEL. BLOOD TEST AND CT SCAN WERE PERFORMED AND THE RESULTS WERE NORMAL. AFTER 3 HOURS IN THE ER HE WAS DISCHARGED WITH A BLOOD GLUCOSE READING OF 128 MG/DL. NO ADDITIONAL DETAILS WERE PROVIDED IN REGARDS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733055 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 54800 - D141211-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention