BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 5871139 · Received August 12, 2016

    Report

    Report Number
    3005862821-2016-00057
    Event Type
    Injury
    Date Received
    August 12, 2016
    Date of Event
    July 8, 2016
    Report Date
    July 8, 2016
    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. THE STANDBY CURRENT TEST IS 1.5-A. THE CRITERIA IS <55-A. 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 55/54 MG/DL, FOR LEVEL HIGH ARE 248/246 MG/DL. THE CONTROL SOLUTION RANGES ARE: LEVEL LOW 30 APPROXIMATELY 80 MG/DL; LEVEL HIGH 190 APPROXIMATELY 290 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS.

    Description of Event or Problem · 1

    OUR IMPORTER, PRODIGY DIABETES CARE RECEIVED A CALL ON (B)(6) 2016 REPORTING A MEDICAL INTERVENTION THAT OCCURRED ON (B)(6) 2016 AT 6:30PM. PATIENT (LM) CALLED IN STATING THAT SHE WANTED TO CHECK HER METER BECAUSE HER METER WAS NOT GIVING HER THE CORRECT READING AND THAT SHE HAD BEEN FEELING NAUSEOUS ALL WEEK. THE READING ON THE PRODIGY METER AT THE TIME OF THE EVENT WAS 146MG/DL. LM'S NORMAL BLOOD GLUCOSE READING AROUND THE TIME OF DAY OF THE EVENT IS 130MG/DL. LM TOOK ALL OF HER REGULAR MEDICATIONS PRIOR TO SEEKING MEDICAL ATTENTION. LM WENT TO ER ON HER OWN WITHOUT CALLING PARAMEDICS. LM'S BLOOD GLUCOSE READING UPON ARRIVAL AT ER WAS 40MG/DL. LM STATED THAT THEY GAVE HER GLUCOSE TO RAISE HER SUGAR LEVEL. LM'S GLUCOSE READING PRIOR TO DISCHARGE WAS 125MG/DL. LM'S TOTAL STAY IN HOSPITAL WAS 4 HOURS. WHEN LM WAS DISCHARGED FROM THE HOSPITAL SHE WENT HOME AND TESTED HERSELF WITH THE PRODIGY METER WITH A 149 MG/DL AND ALSO PERFORMED A CONTROL SOLUTION TEST WITH A RESULT OF 61 MG/DL. PRODIGY SENT REPLACEMENT AND PREPAID ENVELOPE REQUESTING RETURN OF SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525001 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention NOVOLOG 20 UNITS BEFORE EACH MEAL 3 TIMES A DAY