BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY

    MDR report key: 3481322 · Received November 8, 2013

    Report

    Report Number
    3005862821-2013-00026
    Event Type
    Injury
    Date Received
    November 8, 2013
    Date of Event
    July 25, 2013
    Report Date
    August 26, 2013
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, PDC RECEIVED A REPORT OF MEDICAL INTERVENTION THAT OCCURRED ON (B)(6) 2013 AT 4:02 PM. PT CALLED IN SAYING THAT HIS (B)(6) METER WAS GIVING HIM READINGS ALL OVER THE PLACE. RESULTS WERE SAID TO BE 196, 249, 233, 234 AND 247. PER PT, NORMAL READING IS BETWEEN 12-125 MG/DL. PT STATED HAVING HEART PALPITATIONS AND FEELING CLAMMY, SO HE HAD HIS GRANDSON TAKE HIM TO THE HOSPITAL. (B)(6) METER READING PRIOR TO GOING TO ER WAS REPORTED AT 195 MG/DL. UPON ARRIVAL AT ER, THEIR METER READ 207 MG/DL. PT DID NOT SELF-MEDICATE AND/OR DO ANYTHING TO TREAT HIMSELF BETWEEN INITIAL (B)(6) READING AND ER'S. ER SENT PT HOME AND TREATMENT WAS NOT PROVIDED. NO OTHER TESTS CONDUCTED IN HOSPITAL. (B)(6) SENT PT A REPLACEMENT METER W/TS AND CS, AS WELL AS A PREPAID ENVELOPE FOR RETURN OF SUSPECT PRODUCT (S) FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578453 PRODIGY PRODIGY AUTOCODE NBW OK BIOTECH CO., LTD. 51850

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention