BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TDXFLX DIGOXIN II REAGENT

    MDR report key: 103990 · Received July 3, 1997

    Report

    Report Number
    2623532-1997-00018
    Event Type
    Malfunction
    Date Received
    July 3, 1997
    Date of Event
    June 9, 1997
    Report Date
    July 2, 1997
    Manufacturer
    ABBOTT HEALTH PRODUCTS, INC.
    Product Code
    LCS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO INDICATES THE PT WAS IN INTENSIVE CARE FOR ACUTE PYELONEPHRITIS. SHE WAS TREATED WITH ENDOLIPIDS 20% AT 1:30 PM AND AT 2:30 PM BLOOD DRAWS WERE DONE. CODE 81: NO REAGENTS OR CALIBRATORS WERE RETURNED. INVESTIGATION SUMMARY: THE PT SAMPLE WAS HIGHLY LIPEMIC, DUE TO INFUSION OF AN INTRAVENOUS FAT EMULSION PRIOR TO DRAWING A SAMPLE FOR DETERMINATION OF DIGOXIN. THE INITIAL SAMPLE DID NOT CONFORM WITH THE PACKAGE INSERT RECOMMENDATION CONCERNING CENTRIFUGATION TO OBTAIN A CLEAR SUPERNATANT. THE HOSPITAL PERFORMED THE PROPER STUDY TO RESOLVE THE INITIAL HIGH DIGOXIN RESULT. ADEQUATE CENTRIFUGATION OF THE SAMPLE PROVIDED A MORE REALISTIC DIGOXIN CONCENTRATION. IT APPEARS THAT DIGOXIN, A HYDROPHOBIC MOLECULE, HAS THE POTENTIAL TO CONCENTRATE IN LIPID GLOBULES, AND THEN BE CARRIED THROUGH THE TDX/TDXFLX DIGOXIN ASSAY FOLLOWING THE PRE-TREATMENT STEP. THE USE OF IV FAT EMULSION FINDS MORE EXTENSIVE APPLICATION IN EUROPE COMPARED TO NORTH AMERICA AND JAPAN. THE SITUATION WITH THIS PT APPEARS TO BE AN INFREQUENT, IF NOT RARE OCCURRENCE. REVIEW OF TREND ANALYSIS SHOWED NO ADVERSE TRENDS. THE DEVICE HISTORY RECORD REVIEW SHOWED ALL SPECIFICATIONS WERE MET. NO CORRECTIVE ACTION IS REQUIRED. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    ON 6/9/97 A FEMALE PT IN ICU HAD AN INITIAL DIGOXIN RESULT OF 6:1 NM/L OR 4.76 NG/ML. THE SPECIMEN WAS LIPEMIC. A REASSAY OF THIS SAMPLE AFTER CENTRIFUGING AND HARVESTING A LESS LIPEMIC PORTION, RESULTED IN A VALUE OF 2.2 NM/L (1.72 NG/ML). A REASSAY USING THE LIPID-RICH PHASE, CONFIRMED THE INITIAL VALUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TDXFLX DIGOXIN II REAGENT FPIA FOR THE MEASUREMENT OF DIGOXIN LCS ABBOTT HEALTH PRODUCTS, INC. NA 26029Q100

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other