BEUDAMED
    FDA Adverse Event Summary report: N

    FREE LITE HUMAN LAMBDA FREE KIT-OLYMPUS AU SERIES

    MDR report key: 1209263 · Received September 30, 2008

    Report

    Report Number
    1209263
    Date Received
    September 30, 2008
    Date of Event
    September 10, 2008
    Report Date
    September 30, 2008
    Manufacturer
    THE BINDING SITE INC.
    Product Code
    DEH
    Report Source
    User Facility report
    Reporter Location
    NC, US

    Narratives

    Description of Event or Problem · 1

    UPON RECEIPT OF A NEW LOT OF REAGENT (THE BINDING SITE LTD., SAN DIEGO, CA, LOT #257764A)FOR SERUM FREE LIGHT CHAIN LAMBDA, OUR METHOD VALIDATION NOTED A SHIFT BETWEEN LOTS >40%. FREE LAMBDA CHAIN RESULTS DISPLAYED CLINICALLY SIGNIFICANT DIFFERENCES IN 4 OUT OF 5 PATIENTS AS WELL AS KAPPA/LAMBDA RATIO CHANGES IN 3 OUT OF 5 PATIENTS. ====================== MANUFACTURER RESPONSE FOR SPECIFIC LOT # OF REAGENT, FREE LITE HUMAN LAMBDA FREE KIT-OLYMPUS AU SERIES======================IN AN ATTEMPT TO RESOLVE THE PROBLEM, THE DISCREPANT SAMPLES WERE ALSO ASSAYED BY THE MANUFACTURER WHO REPORTED THE SAME DISCREPANCIES, BUT OFFERED NO SOLUTION TO THE PROBLEM. WE SUGGESTED THAT THE MANUFACTURER INFORM OTHER REAGENT USERS OF THE PROBLEM. MANUFACTURER INDICATED THAT THE PROBLEM WAS UNIQUE TO OUR LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREE LITE HUMAN LAMBDA FREE KIT-OLYMPUS AU SERIES REAGENT, MONOCLONAL DEH THE BINDING SITE INC. * LOT# 257764A

    Patients

    Seq Age Sex Outcome Treatment
    1 *