MAUDE Adverse Event Report: THE BINDING SITE LIMITED FREELITE® HUMAN KAPPA FREE KIT FOR USE ON THE ROCHE COBAS® C SYSTEMS

Model Number LK016.CB

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2024

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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 (b)(6) 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 (b)(6) 2024, (b)(6) 2024 and (b)(6) 2024 to the (b)(6) 2024 and the discrepancy was identified by the clinician on (b)(6) 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.

• Brand Name: FREELITE® HUMAN KAPPA FREE KIT FOR USE ON THE ROCHE COBAS® C SYSTEMS
• Type of Device: FREELITE® HUMAN KAPPA FREE KIT FOR USE ON THE ROCHE COBAS® C SYSTEMS
• Manufacturer (Section D): THE BINDING SITE LIMITED; the binding site limited; 8 calthorpe road edgbaston; birmingham, west midlands B15 1 QT; UK B15 1QT
• Manufacturer (Section G): THE BINDING SITE LIMITED; 8 calthorpe road; edgbaston; birmingham, west midlands B15 1 QT; UK B15 1QT
• Manufacturer Contact: richard hughes ; 8 calthorpe road; edgbaston; birmingham, west midlands B15 1-QT ; UK B15 1QT
• MDR Report Key: 18959893
• MDR Text Key: 338572679
• Report Number: 9614373-2024-00001
• Device Sequence Number: 1
• Product Code: DFH
• UDI-Device Identifier: 05051700012096
• UDI-Public: 05051700012096
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LK016.CB
• Device Catalogue Number: LK016.CB
• Device Lot Number: 490912
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2024
• Initial Date FDA Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/11/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other