BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6992577 · Received November 1, 2017

    Report

    Report Number
    3005862821-2017-00118
    Event Type
    Injury
    Date Received
    November 1, 2017
    Date of Event
    October 5, 2017
    Report Date
    October 5, 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 1.0¿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 IN HOUSE STRIPS (STRIP LOT NUMBER:D160526-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 64/61 MG/DL, FOR LEVEL HIGH WERE 253/268 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 1:30 PM AFTER THE END USER PERFORMED A BLOOD GLUCOSE TEST WITH HIS PRODIGY DIABETES METER AND RECEIVED A HIGH READING OF 330 MG/DL. THE END USER EXPERIENCED BLURRED VISION AND DIZZINESS. HE WAS ALSO INITIALLY INSTRUCTED BY HIS PCP TO SEEK MEDICAL ATTENTION IF HE RECEIVES BLOOD GLUCOSE READINGS OVER 200 MG/DL. THE PARAMEDICS WERE CALLED AND UPON ARRIVAL THEY PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND THE RESULT WAS 116 MG/DL. NO TREATMENT WAS ADMINISTERED AND IT WAS NOT NECESSARY TO TRANSPORT THE END USER TO THE ER DUE TO THE FACT THAT HIS BLOOD GLUCOSE READING WAS WITHIN NORMAL RANGE. NO ADDITIONAL DETAILS WERE PROVIDED IN REGARDS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772028 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention FLUDROCORTISONE| ISOSORBIDE| LISINOPRIL| METFORMIN| METOPROLOL| PRAVASTATIN