BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 3552991 · Received December 31, 2013

    Report

    Report Number
    3008789114-2013-00136
    Event Type
    Injury
    Date Received
    December 31, 2013
    Date of Event
    November 23, 2013
    Report Date
    December 4, 2013
    Manufacturer
    OK BIOTECH CO., LTD
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PDC RECEIVED A CALL ON (B)(6) 2013 REPORTING A MEDICAL EVENT THAT OCCURRED ON (B)(6)2013 AT 17:00 HRS. PT (SM) WAS INITIAL CALLER BUT HER DAUGHTER (BB) TOOK OVER CONVERSATION TO GIVE DETAILS OF EVENT. PT BECAME EXTREMELY ALARMED DUE TO THE PRODIGY METER READING OF 474MG/DL. PT'S BLOOD PRESSURE AT THE TIME OF EVENT WAS 150/125. (BB) TESTED PT BLOOD GLUCOSE ON BB'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 COULD STAND ON HER OWN. THEN DAUGHTER (BB) CALLED PARAMEDICS. PARAMEDICS ARRIVED APPROX 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. PT'S NORMAL BLOOD GLUCOSE READINGS ARE 120-140MG/DL. PDC SENT REPLACEMENT AND PREPAID ENVELOPE REQUESTING RETURN OF SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682521 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD 51850

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention RENEXA 1000MG X2| KETOTIFEN 0.25 SOLUTION X2| LANTUS BIOLOSTAR 12 UNITS AT BEDTIME| POTASSIUM-CL 20 EXT TAB X2| HYDRAZALINE 10MG X2| LEVOTHYROXINE 0.1112 X1| FOLIC ACID 1G X1| NYSTATIN O SUSPENSION X4| LEVALBUTEROL 0.63MG AS NEEDED| ASPIRIN 81| ZETIA 10MGX1| OMEPREZOLE 40MG X1| PAROEXTINE 20MGX1| OXYGEN| LIPITOR 20MGX1| CEPHALEXIN 500MG X2| ADVIL 250MG X2| FUROSEMIDE 20MGX2 FOR A TOTAL OF 120MG ALL DAY| ALLOPURINOL 100MG X2| CARVEDILOL 6.25 X2