BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 3957800 · Received July 10, 2014

    Report

    Report Number
    3005862821-2013-00041
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    November 23, 2013
    Report Date
    December 4, 2013
    Manufacturer
    OK BIOTECH CO., LTD
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PDC RECEIVED CA CALL ON (B)(6) 2013 REPORTING A MEDICAL CENTER THAT OCCURRED ON (B)(6) 2013 AT 17:00 HRS. PT (B)(6) WAS INITIAL CALLER BUT HER DAUGHTER (B)(6) TOOK OVER CONVERSATION TO GIVE DETAILS OF EVENT. PT BECAME EXTREMELY ALARMED DUE TO THE PRODIGY METER READING OF 474 MG/DL. PT'S BLOOD PRESSURE AT THE TIME OF EVENT WAS 150/125. (B)(6) TESTED PTS BLOOD GLUCOSE ON (B)(6)'S OWN PERSONAL METER AND RESULTS WERE IN THE 160S. THERE WAS NO TIME FRAME GIVEN BETWEEN THE TWO READINGS. PT HAD RECENTLY BEEN RELEASED FROM THE HOSPITAL AROUND THE TIME OF THE EVENT. PT STATED THAT SHE WASN'T FEELING WELL, WASN'T SPEAKING CORRECTLY, SHAKING AND COULDN'T STAND ON HER OWN. THEN DAUGHTER (B)(6) CALLED PARAMEDICS. PARAMEDICS ARRIVED APPROXIMATELY 20-30 MINUTES LATER. PARAMEDICS PERFORMED BLOOD TEST AND READING WAS 330MG/DL. PT WAS IN HOSPITAL FROM (B)(6) 2013 AND AVERAGE GLUCOSE READINGS WERE IN THE 200S. PTS NORMAL BLOOD GLUCOSE READINGS ARE 120-140 MG/DL. PDC SENT REPLACEMENT AND PREPAID ENVELOP REQUESTING RETURN OF SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403942 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD 51850

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention LIPITOR 20MGX1| ADVIL 250MG X2| NYSTATIN O SUSPENSION X4| LEVALBUTEROL 0.63MG AS NEEDED| CEPHALEXIN 50MG X2| OMEPRAZOLE 40MG X1| PAROEXTINE 20 20MGX1| ALLOPURINOL 100MG X2| LEVOTHYROXINE 0.1112 X1| FOLIC ACID 1G X1| ZETIA 10MGX1| FUROSEMIDE 20MGX2 FOR A TOTAL OF 120MG ALL DAY| OXYGEN| RENEXA 1000MG X2| ASPIRIN 81| LANTUS SOLOSTAR 12 UNITS AT BEDTIME| KETOTIFEN 0.25 SOLUTION X2| POTASSIUM-C1 20 EXT TAB X2| CARVEDILOL 6.25 X2| HYDRAZALINE 10MG X2