MAUDE Adverse Event Report: THE BINDING SITE LIMITED OPTILITE® FREELITE® KAPPA FREE KIT (X10) BULK KIT; OPTILITE® FREELITE® KAPPA FREE KIT (X10) BULK KIT, PRODUCT CODE: DFH

Model Number LK016.10.OPT

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 10/07/2022

Event Type  Injury  

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 the 6th of october 2022, a customer reported to tbs that on the 5th of october 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 on the 6th of october that the sample was re-run which gave a value of >70g/l, see section b6.The customer report was followed up by the binding site to determine if there was an impact on the patient and on the 7th of october 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 on the 7th october 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 the 5th of october 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.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 sent in report on 01nov2022.This report was sent to the fda 03nov2022.(note: this is a resubmission to correct the initial mdr report (titled: binding site inc.3500a 02nov2022) that was sent on nov 3rd, 2022.Upon review (on jan 27, 2023) of the 3rd acknowledgement receipt for the initial submission, it was observed that the 000 added to the importer report number was inputted incorrectly).

• Brand Name: OPTILITE® FREELITE® KAPPA FREE KIT (X10) BULK KIT
• Type of Device: OPTILITE® FREELITE® KAPPA FREE KIT (X10) BULK KIT, PRODUCT CODE: DFH
• Manufacturer (Section D): THE BINDING SITE LIMITED; 8 calthorpe road; birmingham, B15 1 QT; UK B15 1QT
• MDR Report Key: 16280498
• MDR Text Key: 308607570
• Report Number: 0002083566-2023-00001
• Device Sequence Number: 1
• Product Code: DFH
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/01/2023
• Distributor Facility Aware Date: 10/29/2022
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other