BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISION CREATININE

    MDR report key: 95246 · Received May 30, 1997

    Report

    Report Number
    1451914-1997-00026
    Event Type
    Malfunction
    Date Received
    May 30, 1997
    Date of Event
    April 25, 1997
    Report Date
    May 29, 1997
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JFY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON APRIL 25, 1997 THE ACCOUNT GOT A VISION CREATININE RESULT EQUAL TO 1.8 AND THE SAME DAY THE HOSPITAL GOT A RESULT OF 1.1 USING THE SAME SAMPLE. THE CREATININE RESULTS ARE USED TO DOSE CHEMOTHERAPY PATIENTS FOR CHEMOTHERAPY. THE NIGHT BEFORE CHEMOTHERAPY THE PATIENT GETS 20 MG. OF DECADRON AND THE MORNING OF CHEMOTHERAPY GETS 20 MG. OF DECADRON FOR A TOTAL OF 40MG. CHEMOTHERAPY IS TAXOL AND CARBOPLATIN. THE PATIENT RECEIVES COUMADIN 1 MG DAILY AND BENADRYL OVER THE COUNTER FOR SLEEP. THE ACCOUNT STATED THE CUTOFF TO RECEIVE CHEMOTHERAPY IS 1.2 AND THE VISION RESULT WAS 1.8. THE BECKMAN AT THE HOSPITAL GAVE A RESULT EQUAL TO 1.1. INFORMATION NOT KNOWN IF AND FOR HOW LONG TREATMENT WAS DELAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISION CREATININE QUANTITATIVE DETERMINATION OF CREATININE JFY ABBOTT LABORATORIES NA 25323M100

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other