BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6816086 · Received August 24, 2017

    Report

    Report Number
    3005862821-2017-00081
    Event Type
    Injury
    Date Received
    August 24, 2017
    Date of Event
    July 23, 2017
    Report Date
    July 24, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 TEST STRIP. THE STRIP LOT # D160617-1 WAS MANUFACTURED ON 06/17/2016 AND EXPIRED IN 06/2018. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS . WE TOOK OUR IN HOUSE METER AND TESTED THE RETAIN STRIPS (SAME PATIENT'S BATCH#D160617-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 61/61 MG/DL; FOR LEVEL HIGH WERE 257/247 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 .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2017 AT 12:00 PM AFTER RECEIVING HIGHER THAN NORMAL BLOOD GLUCOSE RESULTS FROM HER PRODIGY DIABETES METER. THE END USER PERFORMED A BLOOD GLUCOSE TEST AND RECEIVED A RESULT OF 387 MG/DL. SHE WAS NOT EXPERIENCING ANY SIGNIFICANT SYMPTOMS BUT CONCERN WITH THE HIGHER READING PROMPTED HER TO VISIT THE ER. UPON ARRIVAL TO THE ER HER BLOOD GLUCOSE READING WAS 216 MG/DL. NO TREATMENTS OR TEST WERE WARRANTED DUE TO THE FACT THAT HER BLOOD GLUCOSE WAS WITHIN THE NORMAL RANGE. AFTER 30 MINUTES AT THE ER SHE WAS DISCHARGED WITH A GLUCOSE READING OF 216 MG/DL AND WAS INSTRUCTED TO FOLLOW-UP WITH HER PCP. NO ADDITIONAL DETAILS WERE PROVIDED IN RELATIONS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597758 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. NA D160617-1

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention