MAUDE Adverse Event Report: THE BINDING SITE LIMITED OPTILITE® FREELITE® KAPPA FREE KIT (X10) BULK KIT

Model Number LK016.10.OPT

Device Problem Low Test Results (2458)

Patient Problem Insufficient Information (4580)

Event Date 10/07/2022

Event Type  malfunction  

Event Description

This event did not occur in the usa.We are submitting this report as the event occurred at a healthcare facility in denmark on a device that is similar to a device also marketed in the usa.On (b)(6) 2022, a customer reported to tbs that on (b)(6) 2022, a falsely low serum free light chain value (<0.63 mg/l) was obtained using optilite® freelite® kappa free kit - lk016.10.Opt lot 509854.The customer also reported (b)(6) that the sample was re-run which gave a value of >70g/l, see section laboratory data.The customer report was followed up by the binding site to determine if there was an impact on the patient and on (b)(6) 2022, the customer indicated that there was a 1-day delay in treating the patient.There is no direct indication of patient harm at this time.The binding site's review of the customer's instrument database received (b)(6) 2022 indicated the sample presented a result <0.63mg/l.The initial data from the error report would suggest that the kappa flc result on (b)(6) 2022 was in undetected agxs.Which led to a falsely low result being reported, in addition the k/l ratio was reported as abnormally low.The binding site uk is working with the distributor and the affected health care facility to investigate the case further, including whether there is any impact on the patient.Please note, this incident occurred on lk016.10.Opt lot 509854, which is not registered or sold in the usa.We are reporting because of the similar devices for use on the optilite analyser, which are registered and sold in the usa : lk016.Opt.A, lk016.10.Opt.A, lk016.M.Opt.A.

Manufacturer Narrative

Initial indications from the error reports suggest that the kappa flc result on the (b)(6) 2022 was in undetected antigen excess (agxs).Which led to a falsely low result being reported, in addition the k/l ratio was reported as abnormally low.Due to the investigation indicating undetected antigen excess, we have determined the type of reportable event (h1) as a malfunction.It also states in the product ifu section 1 - intended use, that the assay is to used in conjunction with other laboratory and clinical findings.We are yet to confirm with the site if the assay was used in isolation, as this could indicate user error as a root cause.The potential for undetected agxs is known to be a limitation of all nephelometric and turbidimetric assays.This is specifically referred to in the product ifu section 8.6: i.All immunoassays have the potential for antigen excess.In order to identify samples that are in antigen excess the optilite has the facility to monitor reaction kinetics.Ii.If a sample gives a result that is considered implausible, the sample should be retested.Iii.Important note: no automated check will identify all cases of antigen excess and a very small percentage of samples in antigen excess have normal reaction kinetics so will not prompt the ha or ac flag.Iv.It is recommended that the following statement accompany all free light chain results "undetected antigen excess is a rare event but cannot be excluded.If these free light chain results do not agree with other clinical or laboratory findings, or if the sample is from a patient that has previously demonstrated antigen excess, the result must be checked by retesting at a higher sample dilution.Results should always be interpreted in conjunction with other laboratory tests and clinical evidence; any anomalies should be discussed with the testing laboratory." although the sample has not been made available, the investigation to date suggests that this is a sample specific issue of undetected antigen excess rather than an issue with the kit lot in question.This is supported by the elevated result of the follow up sample, although this continues to be investigated.We have also spoken to a clinical haematologist, who suggested further questions to be asked to support our investigation.The binding site uk is working with the distributor and the affected health care facility to investigate the case further, including whether there is any impact on the patient.This includes determination of the following: 1) the status of the patient and their response to treatment, 2) the treatment(s) under question, 3) additional details on the sequence of events, and patient history, 4) available additional laboratory results, including available renal function data.

• Brand Name: OPTILITE® FREELITE® KAPPA FREE KIT (X10) BULK KIT
• Type of Device: OPTILITE® FREELITE® KAPPA FREE KIT (X10) BULK KIT
• Manufacturer (Section D): THE BINDING SITE LIMITED; 8; calthorpe road; birmingham, B15 1 QT; UK B15 1QT
• Manufacturer (Section G): THE BINDING SITE GROUP LIMITED; 8; calthorpe road; birmingham, gbr B15 1 QT; UK B15 1QT
• Manufacturer Contact: richard hughes ; 8; calthorpe road; birmingham, gbr B151Q-T ; UK B151QT
• MDR Report Key: 15710058
• MDR Text Key: 307581082
• Report Number: 3012471076-2022-00001
• Device Sequence Number: 1
• Product Code: DFH
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K150658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 05/31/2023
• Device Model Number: LK016.10.OPT
• Device Catalogue Number: LK016.10.OPT
• Device Lot Number: 509854
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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