BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6826298 · Received August 29, 2017

    Report

    Report Number
    3005862821-2017-00087
    Event Type
    Injury
    Date Received
    August 29, 2017
    Date of Event
    July 31, 2017
    Report Date
    July 31, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE AND STRIPS WERE RETURNED AND EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS BUT STRIPS WERE MOIST. WE TESTED THE STANDBY CURRENT OF RETURNED METER, THE RESULTS WAS 3.1UA. 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:D160826-2 ). THE CONTROL SOLUTION TESTS FOR LEVEL LOW ARE 209/236 MG/DL, FOR LEVEL HIGH ARE 388/405 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~80 MG/DL; LEVEL HIGH 190~290 MG/DL. ALL RESULTS WERE OUT OF THE ACCEPTANCE RANGE. NG. WE TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND RETAIN STRIPS FROM OUR WAREHOUSE (SAME BATCH AS PATIENT'S STRIPS,LOT #D160809-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 72/64 MG/DL; FOR LEVEL HIGH WERE 252/242 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 . ACCORDING TO ABOVE TESTS, WE FOUND THE METER WAS OPERATED WITHIN SPECIFICATION BUT RESULT OF INCORRECT READINGS FROM PATIENT'S STRIP MIGHT BE BECAUSE PATIENT STORED THE STRIPS IN AN UNCONTROLLED OR IMPROPER ENVIRONMENT AND LED TO STRIPS MOIST AND PRODUCED INCORRECT HIGH READINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT AFTER THE END USER RECEIVED HIGHER THAN NORMAL BLOOD GLUCOSE RESULTS FROM HIS PRODIGY DIABETES METER. THE END USER COULD NOT RECALL THE ACTUAL DATE OF THE MEDICAL INTERVENTION. THE END USER FELT WEAK, COLD, WAS SHAKING AND THEN FELT HOT ACCOMPANIED WITH A BLOOD GLUCOSE READING OF 560 MG/DL. HE WAS TAKEN TO THE ER AND UPON ARRIVAL HIS BLOOD GLUCOSE WAS 57 MG/DL. WHILE AT THE ER HE RECEIVED CRACKERS AND ORANGE JUICE. AFTER 3 HOURS HE WAS DISCHARGED WITH A BLOOD GLUCOSE READING OF 125 MG/DL AND INSTRUCTED TO FOLLOW-UP WITH HIS PCP. NO ADDITIONAL DETAILS WERE PROVIDED IN REGARDS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608676 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800 - D160826-2

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention AMLODIPINE 10 MG ONCE A DAY| ASPIRIN 81 MG ONCE A DAY| ATORVASTATIN 20 MG ONCE A DAY| GABAPENTIN 600 MG THREE TIMES A DAY| GLIPIZIDE 10 MG 1 TAB AM & PM| LEVEMIR FLEX 25 UNITS TWICE A DAY| VALSARTAN 3/25 MG ONCE A DAY