BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6766344 · Received August 4, 2017

    Report

    Report Number
    3005862821-2017-00074
    Event Type
    Injury
    Date Received
    August 4, 2017
    Date of Event
    June 20, 2017
    Report Date
    July 5, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 1.2A. THE CRITERIA IS <55A. 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 61/59 MG/DL, FOR LEVEL HIGH WERE 243/260 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 5:30 PM AFTER THE END USER RECEIVED HIGHER THAN NORMAL BLOOD. GLUCOSE RESULTS FROM HER PRODIGY DIABETES METER. THE END USER WAS DROWSY, FELT SLEEPY, CONFUSED AND FAINTED. HER BLOOD GLUCOSE READING AT THE TIME OF THIS MEDICAL EVENT WAS 141 MG/DL. THE PARAMEDICS WERE CALLED AND PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND THE RESULT WAS 65 MG/DL. A BLOOD GLUCOSE TEST WAS ALSO PERFORMED WITH HER PRODIGY METER AND THE RESULT WAS 135 MG/DL. THE PARAMEDICS ADMINISTERED AN UNKNOWN TREATMENT TO ASSIST IN STABILIZING HER BLOOD GLUCOSE LEVEL. NO ADDITIONAL DETAILS WERE PROVIDED IN RELATIONS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548008 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention ENALAPRIL| LEVOTHYROXINE| METOPROLOL| NOVOLIN 15 UNITS PM| NOVOLIN 25 UNITS AM| PAROXETINE| RANITIDINE| SIMVASTATIN| TOLTERODINE