BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGOXIN REAGENT

    MDR report key: 1000369 · Received February 18, 2008

    Report

    Report Number
    MW5005586
    Event Type
    Malfunction
    Date Received
    February 18, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 18, 2008
    Manufacturer
    BECKMAN COULTER, INC
    Product Code
    KXT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE UCH CLINICAL LABORATORY EXPERIENCED LOW RECOVERY OF DIGOXIN IN ITS ASSAY AS IDENTIFIED BY CARE PROVIDERS. DATE RANGE OF LOW RECOVERY APPEARS TO BE IN 2007 THROUGH 2008. PROBLEM FIRST BROUGHT TO LAB'S ATTENTION APPROX JAN 31, 2008. INVESTIGATION SHOWED DETERIORATION OF CALIBRATION 5-7 DAYS AFTER CALIBRATION -MFG STATES WITHIN- LOT CALIBRATION STABILITY OF 42 DAYS-. VENDOR WAS CONTACTED 2-1-08 BY LAB TO DISCUSS ISSUE. VENDOR SHIPPED NEW LOT NUMBER OF CALIBRATOR AND REAGENT WHICH WAS PLACED IN USE 2008. LAB NOTIFIED ON 2-14-08 BY CARE PROVIDER OF QUESTIONABLE LOW RESULT. LAB REVIEWED QC AND NOTED EXCELLENT PERFORMANCE WITH NO INDICATION OF BIAS, TRENDING, OR IMPRECISION. DIGOXIN ASSAY WAS CALIBRATED ON ANOTHER ANALYZER -SAME MODEL-, SAMPLE WAS RETESTED AND RESULTS WERE COMPARABLE TO FIRST ANALYZER. SAMPLE SENT TO TWO OTHER HOSPITALS IN TOWN WHICH USE DIFFERENT PLATFORMS/METHODOLOGIES FOR COMPARISON TESTING; THEIR RECOVERY WAS WHAT WAS EXPECTED GIVEN THE PT'S HISTORY. DIGOXIN TESTING HAS BEEN SUSPENDED FROM THE UCH ANALYZERS UNTIL RESOLUTION IS IDENTIFIED. DATES OF USE: 2007 -- 2008, DIAGNOSIS: LABORATORY TESTING FOR THERAPEUTIC LEVELS OF DRUG, EVENT REAPPEARED AFTER REINTRODUCTION: #1 - YES, #2 - YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIGOXIN REAGENT NONE KXT BECKMAN COULTER, INC
    2 DIGOXIN CALIBRATOR NONE KXT BECKMAN COULTER, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other