BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 4484773 · Received December 26, 2014

    Report

    Report Number
    3005862821-2014-00034
    Event Type
    Injury
    Date Received
    December 26, 2014
    Date of Event
    November 6, 2014
    Report Date
    November 12, 2014
    Manufacturer
    OK BIOTECH CO., LTD
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CONCLUDED THAT THE METER AND STRIPS OPERATED WITHIN SPECIFICATIONS. THE METER CURRENT TEST IS 1.6UA. THE CRITERIA IS <55UA. PASS. METER SETTING, AUDIO AND ALL BUTTONS WERE OK. TESTED THE SUSPECTED METER WITH SUSPECTED STRIP AND RETAINED STRIPS WITH IN HOUSE CONTROL SOLUTION. THE READINGS OF CONTROL SOLUTION TEST FOR LOW LEVEL ARE: 36/37/35/32 MG/DL; FOR HIGH LEVEL ARE: 228/226/241/238 MG/DL, THE REQUEST GCS RANGE IS LOW: 25 APPROXIMATELY 70 MG/DL; HIGH: APPROXIMATELY 200 - 300 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTABLE RANGE.

    Description of Event or Problem · 1

    PDC RECEIVED A CALL ON (B)(6) 2014 REPORTING A MEDICAL INTERVENTION THAT OCCURRED ON (B)(6) 2014 AROUND 2:00 PM. PT (RP) WAS AWAY FROM HOME WHEN THE ACTUAL EVENT OCCURRED. PT'S BLOOD GLUCOSE READING BEFORE HE LEFT HOME WAS 163MG/DL. WHILE AWAY FROM HOME, PT STATED THAT HIS BLOOD GLUCOSE LEVEL WAS LOW AND HE WAS FEELING LIGHTHEADED, SHAKING AND SWEATING. PT WAS TAKEN HOME BY AN UNIDENTIFIED PERSON. PARAMEDICS WERE CALLED 4 HOURS AFTER THE INITIAL TESTING WITH THE PRODIGY METER. PT STATED THAT PARAMEDICS PERFORMED GLUCOSE TEST BUT HE DID NOT REMEMBER THE RESULTS. PT STATED THAT PARAMEDICS INFORMED HER THAT THE PRODIGY METER TEST RESULTS WERE 40 POINTS HIGHER THAN THEIRS. PT WAS NOT TAKEN TO EMERGENCY ROOM. PT WAS ADMINISTERED GLUCOSE TUBE BY PARAMEDICS. PDC SENT REPLACEMENT AND PREPAID ENVELOPE REQUESTING RETURN OF SUSPECT DEVICE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852613 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD 51850 D130731-1

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention HUMALOG 20-75