MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH N LATEX FLC LAMBDA; LAMBDA, ANTIGEN, ANTISERUM, CONTROL

Catalog Number	10873630
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An united states (us) customer contacted a siemens regional support center to report the observation of discordant n latex flc lambda results on a atellica ch 930 instrument.Quality control results were within acceptable ranges on the day of testing.Per the intended use section of the n latex flc lambda instructions for use (ifu): "results of the flc measurement should always be interpreted in conjunction with other laboratory findings." customer also reran several other samples from the initial date/time, and no other samples were discordant.Siemens is investigating.
Event or Problem Description
The customer reported a falsely depressed n latex flc lambda result was obtained on a patient sample on a atellica ch 930 instrument.The erroneous result was reported to the physician(s).The sample was repeated on the same instrument.The repeat result was higher than the erroneous result.The repeat result was reported, as the correct result, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed n latex flc lambda result.

• Brand Name: N LATEX FLC LAMBDA
• Common Device Name: LAMBDA, ANTIGEN, ANTISERUM, CONTROL
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg 35041 ; GM 35041
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg 35041 ; GM 35041
• Manufacturer Contact: monika bornmann ; emil-von-behring- str. 76; marburg 35041 ; GM 35041 ; 915121287564
• MDR Report Key: 24825322
• Report Number: 9610806-2026-00008
• Device Sequence Number: 13046394
• Product Code: DEH
• UDI-Device Identifier: 00630414167664
• UDI-Public: (01)00630414167664(10)473210(17)261113
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K212379
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 10873630
• Device Lot Number: 473210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown