BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 3760618 · Received April 9, 2014

    Report

    Report Number
    3008789114-2014-00013
    Event Type
    Injury
    Date Received
    April 9, 2014
    Date of Event
    March 8, 2014
    Report Date
    March 10, 2014
    Manufacturer
    OK BIOTECH CO, LTD
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    SC, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    PDC RECEIVED A CALL ON (B)(6) 2014 REPORTING A MEDICAL ATTENTION THAT OCCURRED ON (B)(6) 2014 BETWEEN 5:30 - 5:45PM. PT'S WIFE (B)(6) STATED THAT PT'S BLOOD SUGAR WAS TOO LOW. PT DISPLAYED SIGNS OF LOOPINESS AND FELL OUT OF A CHAIR. THE READING ON THE PRODIGY METER AT THE TIME OF THE EVENT WAS 72MG/DL. PARAMEDICS WERE CALLED IMMEDIATELY. PT WAS GIVEN A SODA WHILE WAITING ON PARAMEDICS. PARAMEDICS PERFORMED A BLOOD GLUCOSE TEST WITH A RESULT OF 58 MG/DL. APPROX 3-4 MINUTES PASSED BETWEEN TESTING WITH THE PRODIGY METER AND THE PARAMEDIC'S METER. PT WAS GIVEN A GLUCOSE TUBE AND WAS NOT TRANSPORTED TO THE ER. PDC SENT REPLACEMENT AND PREPAID ENVELOPE REQUESTING RETURN OF SUSPECT PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213066 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO, LTD 51850

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention RENVELA-800MG-2TIMES BY MOUTH X3| HYDRAZALINE 50MG X3| INSULIN 30 UNITS (MORNING) 15 UNITS (EVENING)| FUROSEMIDE 80MG X3| CLONIDINE .01MG X2| ANTENOLOL 50MG X1| DILTIAZEM 180 MG X2| ASPIRIN X1| NOVOLOG 70/30 FLEXPEN| AMITRIPTYLINE 25 MG AT BEDTIME| SENSIPAR 30MG X1| LISINOPRIL40MG/DL X1| ATORVASTATIN 40MG X1