MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH N LATEX FLC LAMBDA

Model Number N LATEX FLC LAMBDA

Device Problem Low Test Results (2458)

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

Event Date 04/22/2021

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range at the time of the event.The issue was limited to one patient sample.No issues were identified with the system or reagent.The cause of the event is unknown.The reagent is performing according to specifications.No further evaluation of this device is required.Mdrs 9610806-2021-00046 and 9610806-2021-00047 were filed for the discordant results obtained on (b)(6) 2021, respectively.

Event Description

A discordant, falsely low free light chains, type lambda (flc lambda) result was obtained on a patient sample using a 1:20 dilution on an atellica neph 630 system using n latex flc lambda reagent.The discordant result was reported to the physician(s) and was questioned by the physician(s).The same sample was repeated for flc lambda on a non-siemens system using a non-siemens reagent, recovering higher.The result from the non-siemens system was reported, as the correct result, to the physician(s).The sample was repeated again for flc lambda five days later using a 1:20 dilution on the same atellica neph 630 system using n latex flc lambda reagent, recovering low.The following day, the sample was repeated three more times for flc lambda, twice using a 1:20 dilution and once using a 1:5 dilution, recovering low.These repeat results were not reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low flc lambda results.

Manufacturer Narrative

Siemens filed the initial mdr 9610806-2021-00045 on 21-may-2021.Additional information (15-jun-2021): additional investigation determined that quality controls (qc) were run using the n latex flc lambda reagent and recovered in range.The affected sample was analyzed on the size exclusion column (sec) and bound light chains in immunoglobulin a-lambda (iga-lambda) were separated from free light chains, type lambda (flc lambda).The low flc lambda result in this sample was not related to the presence of high levels of iga.It was determined that the falsely low results with this particular sample were not related to a malfunction of the n latex flc lambda assay, but more related to a sample specific issue, whereby the cause of the event is unknown.The reagent is performing according to specifications.No further evaluation of this device is required.Mdrs 9610806-2021-00046_s1 and 9610806-2021-00047_s1 were also filed for the additional information obtained on 15-jun-2021.

• Brand Name: N LATEX FLC LAMBDA
• Type of Device: N LATEX FLC LAMBDA
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring-str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 11863629
• MDR Text Key: 262223430
• Report Number: 9610806-2021-00045
• Device Sequence Number: 1
• Product Code: DEH
• Combination Product (y/n): N
• PMA/PMN Number: K182098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/17/2021
• Device Model Number: N LATEX FLC LAMBDA
• Device Catalogue Number: 10482438
• Device Lot Number: 473257
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/29/2021
• Initial Date FDA Received: 05/21/2021
• Supplement Dates Manufacturer Received: 06/15/2021
• Supplement Dates FDA Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR