BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 4290524 · Received November 25, 2014

    Report

    Report Number
    3008789114-2014-00034
    Event Type
    Injury
    Date Received
    November 25, 2014
    Date of Event
    November 6, 2014
    Report Date
    January 7, 2016
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    .

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

    Description of Event or Problem · 1

    THIS IS A SUPPLEMENTAL REPORT TO INITIAL REPORT 3008789114-2014-00034 TO SUBMIT INFORMATION FROM THE MANUFACTURER TO CLOSE OUT THE REPORT. ADDITIONAL INFORMATION IS AS FOLLOWS: SUSPECTED DEVICE EVALUATED BY (B)(4) 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:25~70 MG/DL;HIGH:200~300 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTABLE RANGE. REFERENCE MANUFACTURER REPORT# 3005862821-2014-00034.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766310 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention