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

Model Number N LATEX FLC LAMBDA

Device Problem High Test Results (2457)

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

Event Date 07/22/2021

Event Type  malfunction  

Manufacturer Narrative

An outside of the united states (ous) customer contacted their national competent authority who contacted siemens.Due to a changed calibrator, the customer experienced 40% higher values for free light chains, type lambda (flc lambda) results for both quality controls (qc) and patient samples.Due to the issue, follow-up was no longer possible for myeloma patients.Siemens is investigating the issue.

Event Description

A discordant free light chains, type lambda (flc lambda) result was obtained on a patient sample on a bn prospec system using n latex flc lambda reagent.It is unknown if the discordant result was reported to the physician(s).It is unknown what the correct result for the patient is.There are no known reports of patient intervention or adverse health consequences due to the discordant flc lambda result.

Manufacturer Narrative

Siemens filed the initial mdr 9610806-2021-00070 on 23-nov-2021.Additional information (07-jan-2022): siemens performed proficiency testing using n latex flc lambda reagent lot 473261, as the complained reagent lot was expired and no longer available.The reagent was calibrated against all lots of the n flc standard sl that were in shelf life.All calibration curves were valid.All lots of the n flc control sl1 and n flc control sl2 that were in shelf life were run.The quality controls (qc) recovered within the assigned ranges, independent of the standard lot used.Patient and survey sample testing recovered acceptably.The recalculated n latex flc lambda values of the patient and survey samples using the different calibration curves were comparable.The customer's issue could not be reproduced.The cause of the event is unknown.The investigation findings and investigation conclusions codes in section h6 of the mdr were updated to reflect the additional information.The reagent is performing according to specifications.No further evaluation of this device is required.

• 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
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring-str. 76; marburg, D-350 41; GM D-35041
• Manufacturer Contact: christopher aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 12862105
• MDR Text Key: 288303076
• Report Number: 9610806-2021-00070
• Device Sequence Number: 1
• Product Code: DEH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K182098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/02/2022

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: 10/18/2021
• Device Model Number: N LATEX FLC LAMBDA
• Device Catalogue Number: 10482438
• Device Lot Number: 473258A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2021
• Initial Date FDA Received: 11/23/2021
• Supplement Dates Manufacturer Received: 01/07/2022
• Supplement Dates FDA Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Female