BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6127126 · Received November 24, 2016

    Report

    Report Number
    3005862821-2016-00106
    Event Type
    Injury
    Date Received
    November 24, 2016
    Date of Event
    October 26, 2016
    Report Date
    October 26, 2016
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. THE STANDBY CURRENT TEST IS 1.6UA. THE CRITERIA IS <55UA. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. 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 ARE 63/65 MG/DL, FOR LEVEL HIGH ARE 285/279 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) 2016 AT 7:30AM DUE TO THE END USER RECEIVING INCONSISTENT BLOOD GLUCOSE RESULTS FROM THE PRODIGY DIABETES METER. THE END USER RECEIVED A READING OF 98 MG/DL AND BECAME ALARMED. SHE VISITED HER PCP AND UPON ARRIVAL HER BLOOD GLUCOSE WAS 135 MG/DL. NO TREATMENT WAS ADMINISTERED AND SHE WAS INSTRUCTED TO DECREASE HER INSULIN TO 20 UNITS PER DAY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777837 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800-D160104-1

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention AMIODARONE-BENADRYL| DAILY ESSENTIAL VITAMINS| LANTUS| LUTEIN| MITIGLINIDE| THYROXINE