MAUDE Adverse Event Report: THE BINDING SITE GROUP LIMITED FREELITE HUMAN LAMBDA FREE KIT FOR USE ON THE SPAPLUS

Model Number LK018.S

Device Problems Improper or Incorrect Procedure or Method (2017); Low Test Results (2458)

Patient Problem Renal Failure (2041)

Event Date 01/08/2020

Event Type  Injury  

Event Description

This is a duplicate copy of the mdr filed by our parent company (the manufacturer of the device), binding site group limited, located in (b)(4).This duplicate copy of the mdr is being filed due to 803 subpart d which establishes importer reporting requirements (binding site inc., usa) and subpart e establishes manufacturer reporting requirements, although it is for the same event, each firm (importer and manufacturer) should report the mdr if it meets these requirements.This event did not occur in the usa.We are submitting this report as the event occured at a healthcare facility in (b)(6) on a device that is also marketed in the usa.The resulting complaint and investigation were coordinated between the binding site (b)(4), the manufacturer of the device, and the binding site (b)(4), the sponsor of the device in (b)(4).On (b)(6) 2019 a patient sample was tested using the binding site's freelite lambda free kit for use on the spaplus, at a healthcare facility in (b)(6).This gave a final free lambda result of 151 mg/l (95 percentile reference interval: 5.71 - 26.30 mg/l), with no antigen excess check flag.This result was subsequently reported to the physician.The patient was treated for their myeloma.The patient developed acute renal failure and was admitted to the icu on (b)(6) 2020, and placed on dialysis.A new sample was tested on (b)(6) 2020 which gave a result of 27,454 mg/l.Subsequently the sample which was tested and retained on (b)(6) 2019 was thawed and retested, and a final result of 17,182 mg/l obtained.The treating physician commented that had a freelite result of 17,182 mg/l been reported to them when the sample was originally tested on (b)(6) 2019, they would have chosen an alternate course of treatment for the patient which the physician stated may have prevented their presentation with acute renal failure.The binding site's review of the customer's instrument database indicated that when the patient sample was tested on (b)(6) 2019 this did not prompt a prozone flag as the sample results were below the minimum parameter limits for this kit.When the serum lambda free light chain result of 151 mg/l was reported on 06/dec/19 there were a number of other patient results available including: serum electrophoresis (epg) (free lambda = 4 g/l; igg lambda = 34 g/l), urine electrophoresis (upe) (free lambda = 3.2 g/l) which were inconsistent with the serum free light chain result.We also understand that egfr and creatinine were 56 ml/min/1.73m2 and 88 umol/l respectively.When the sample from the (b)(6) 2019 was retested on (b)(6) 2020 the initial result reported at the standard dilution was >157 mg/l and reflexed to subsequent dilutions and a final result of 17,182 mg/l including a prozone flag was returned.The binding site therefore believes it is most likely that the sample was in antigen excess.

• Brand Name: FREELITE HUMAN LAMBDA FREE KIT FOR USE ON THE SPAPLUS
• Type of Device: FREELITE HUMAN LAMBDA FREE KIT FOR USE ON THE SPAPLUS
• Manufacturer (Section D): THE BINDING SITE GROUP LIMITED; 8 calthorpe road; birmingham, B151Q T; UK B151QT
• MDR Report Key: 9769714
• MDR Text Key: 196109233
• Report Number: 0002083566-2020-00001
• Device Sequence Number: 1
• Product Code: DEH
• UDI-Device Identifier: 05051700006477
• UDI-Public: 05051700006477
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: LK018.S
• Device Catalogue Number: LK018.S
• Device Lot Number: 424735
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/28/2020
• Distributor Facility Aware Date: 02/18/2020
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR