BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6826293 · Received August 29, 2017

    Report

    Report Number
    3005862821-2017-00083
    Event Type
    Injury
    Date Received
    August 29, 2017
    Date of Event
    July 24, 2017
    Report Date
    July 25, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, 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 07/19/2013. THE STRIP LOT # D150529-1 WAS MANUFACTURED ON 05/29/2015 AND WAS EXPIRED IN MAY 2017. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS . PATIENT USED EXPIRED STRIPS TO TEST BLOOD WHICH MIGHT CAUSED OR CONTRIBUTED TO ERROR READINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2017 AT 9:30 AM AFTER THE END USER RECEIVED HIGHER THAN NORMAL BLOOD GLUCOSE RESULTS FROM HIS PRODIGY DIABETES METER. THE END USER WAS NOT ABLE TO SPEAK, STAND UP OR SEE AND HIS BLOOD GLUCOSE READING AT THE TIME OF THE MEDICAL EVENT WAS 166 MG/DL. ADDITIONAL BLOOD GLUCOSE TESTS WERE PERFORMED WITH RESULTS RANGING FROM 128 MG/DL - 291 MG/DL. THE PARAMEDICS WERE CALLED AND PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER WITH A RESULT OF 35 MG/DL. HE WAS GIVEN TWO LIQUID SUGAR PACKETS ALONG WITH JUICE AND TRANSPORTED TO THE ER. UPON ARRIVAL TO THE ER THE END USER WAS GIVEN FOOD AND CLOSELY MONITORED. A CHEST X-RAY WAS PERFORMED AND AFTER A FEW HOURS AT THE ER HE WAS DISCHARGED AND INSTRUCTED TO CONTINUE MONITORING HIS BLOOD GLUCOSE AND 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
    608499 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800 - D150529-1

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention