BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 7551936 · Received May 30, 2018

    Report

    Report Number
    3005862821-2018-00032
    Event Type
    Injury
    Date Received
    May 30, 2018
    Date of Event
    April 7, 2018
    Report Date
    May 2, 2018
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384840518858
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. 1. WE TESTED THE STANDBY CURRENT OF RETURNED METER, THE RESULT WAS 1.4A. THE CRITERIA IS <55A. PASS. 2. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. 3. WE TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND RETURNED STRIPS (STRIP LOT NUMBER:D170116-1 ). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 64/64 MG/DL, FOR LEVEL HIGH WERE 270/263 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~85 MG/DL; LEVEL HIGH 210~320 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS. 4. WE TESTED THE RETAIN STRIPS (STRIP LOT NUMBER:D170116-1) WITH RETURNED METER. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 65/63 MG/DL; FOR LEVEL HIGH WERE 266/263 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~85 MG/DL; LEVEL HIGH 210~320 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS.

    Description of Event or Problem · 1

    REPORTER ALLEGED THAT MEDICAL ATTENTION WAS SOUGHT FOR END-USER ON (B)(6) 2018 AT 1619 DUE TO BEING FOUND UNRESPONSIVE BY REPORTER. REPORTER STATED SHE TESTED ON THE PRODIGY METER AND RECEIVED A 67 MG/DL AND IMMEDIATELY CALLED THE PARAMEDICS. WHILE WAITING FOR THE PARAMEDICS THE REPORTED STATED SHE GAVE THE END-USER ORANGE JUICE. THE PARAMEDICS ARRIVED IN 15 MINUTES AND TESTED THE END-USER'S BLOOD GLUCOSE, RESULT WAS 33 MG/DL. PARAMEDICS ADMINISTERED IV SOLUTION (UNKNOWN CONCENTRATION). ENDUSER WAS TRANSPORTED TO THE HOSPITAL. UPON ARRIVAL AT THE HOSPITAL A BLOOD GLUCOSE TEST WAS PERFORMED BUT THE REPORTED CANNOT RECALL THE RESULT. NO TREATMENT WAS USED TO RAISE OR LOWER THE END-USER'S BLOOD GLUCOSE LEVEL. END-USER WAS IN THE HOSPITAL FOR APPROXIMATELY 3 HOURS AND RECEIVED A BREATHING TREATMENT. AT DISCHARGE THE END-USER WAS PRESCRIBED PREDNISONE, NO OTHER INSTRUCTIONS PROVIDED. NO OTHER INFORMATION WAS PROVIDED ABOUT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396879 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. D170116-1 00384840518858

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention ALLOPURINOL| AMITIZA| ATORVASTATIN| CARVEDILOL| DALIRESP| DIGOXIN| DILTIAZEM| FLUTICASONE| HUMALOG| LISINOPRIL| LYRICA| NITROGLYCERIN| PRAMIPEXOLE| PRO AIR - INHALER| SERTRALINE| SUCRALFATE| SYNTHROID| TOUJEO| TRAMADOL| TRAZODONE