BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREELITE® HUMAN KAPPA FREE KIT FOR USE ON THE ROCHE COBAS® C SYSTEMS

    MDR report key: 18993740 · Received March 28, 2024

    Report

    Report Number
    2083566-2024-00002
    Event Type
    Injury
    Date Received
    March 28, 2024
    Date of Event
    February 8, 2024
    Report Date
    March 27, 2024
    Manufacturer
    THE BINDING SITE LIMITED
    Product Code
    DFH
    UDI-DI
    05051700012096
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE OF THE FAILURE HAS NOT YET BEEN DETERMINED, AND INVESTIGATIONS ARE ONGOING. THERE IS CURRENTLY NO INDICATION OF AN ISSUE WITH THE ASSAY LOT (PRODUCT CODE: LK016.CB, KIT LOT: 490912) AND THERE HAVE BEEN NO SIMILAR COMPLAINTS RAISED ON THIS ASSAY LOT.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE BINDING SITE (PDX) ON THE 08TH OF FEBRUARY 2024 TO REPORT THAT THEIR PDX FREELITE® HUMAN KAPPA FREE KIT FOR USE ON THE ROCHE COBAS® C SYSTEMS ASSAY (PRODUCT CODE: LK016.CB, KIT LOT: 490912) WAS PRODUCING UNUSUALLY HIGH KAPPA RESULTS ON ONE OF THEIR INSTRUMENTS. ON THE 27TH OF FEBRUARY 2024, THE CUSTOMER INFORMED PDX THAT 20 RESULTS RELEASED FROM THE LABORATORY FOR KAPPA FREE WERE FALSELY ELEVATED. 15 OF THESE RESULTS WERE ABOVE THE TOTAL ALLOWABLE ERROR (TEA) OF 40% OF THE ASSAY. THE TESTING TOOK PLACE ON THE 24TH JANUARY 2024, 02ND FEBRUARY 2024 AND 04TH FEBRUARY 2024 TO THE 07TH FEBRUARY 2024 AND THE DISCREPANCY WAS IDENTIFIED BY THE CLINICIAN ON 08TH FEBRUARY 2024. UPON REPEAT TESTING ON AN ADDITIONAL ANALYSER, THE CUSTOMER OBTAINED RESULTS WHICH THEY REPORTED TO BE MORE IN LINE WITH THE CLINICAL PICTURE. THE CUSTOMER REPORTED THAT FOR THE INITIAL INSTRUMENT THE ISSUE WAS RESOLVED FOLLOWING REPLACEMENT OF A SAMPLE PROBE AND A NEW KIT LOT. ALTHOUGH NO REPORTS HAVE BEEN RECEIVED OF HARM TO PATIENTS, CHANGE IN PATIENT MANAGEMENT OR INAPPROPRIATE THERAPY, THE DECISION WAS TAKEN TO REPORT AS A MATTER OF CAUTION. IF THE ERROR WERE TO RECUR FOR 1 OF THE 15 RELEASED DISCREPANT RESULTS ABOVE THE TEA THERE IS A REMOTE POSSIBILITY OF IT LEADING TO SERIOUS INJURY. FOR THIS SAMPLE THE FALSELY ELEVATED FREE LIGHT CHAIN (FLC) KAPPA VALUE WAS 643 MG/L WHEREAS ON REPEAT THE VALUE RETURNED WAS 0.63MG/L (BELOW THE REFERENCE RANGE; 3.30 - 19.40 MG/L). SHOULD THE ERROR RECUR THERE IS A POTENTIAL FOR PATIENT MANAGEMENT TO BE CHANGED, IF THE ASSAY RESULT IS USED IN ISOLATION. IN A DIAGNOSTIC SCENARIO, THIS ISSUE COULD LEAD TO A FALSE DIAGNOSIS OF MYELOMA AND SUBSEQUENT TREATMENT ON THE BASIS OF THE FLC CRITERION OF THE SLIM CRITERIA (INVOLVED/UNINVOLVED FLC EQUAL TO OR GREATER THAN 100, PROVIDED THAT THE INVOLVED FLC IS EQUAL TO OR GREATER THAN 100MG/L) IN THE PRESENCE OF MORE THAN 10% BONE MARROW PLASMA CELLS. AS PER THE INSTRUCTIONS FOR USE OF THE ASSAY (SIN129), RESULTS OF THIS ASSAY SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL EXAMINATIONS, AND OTHER FINDINGS INCLUDING PREVIOUS FREELITE RESULTS IF AVAILABLE. CASE INVESTIGATION IS CONTINUING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723698 FREELITE® HUMAN KAPPA FREE KIT FOR USE ON THE ROCHE COBAS® C SYSTEMS FREELITE® HUMAN KAPPA FREE KIT FOR USE ON THE ROCHE COBAS® C SYSTEMS DFH THE BINDING SITE LIMITED LK016.CB 490912 05051700012096

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other