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 11/15/2021

Event Type  malfunction  

Manufacturer Narrative

An outside of the united states (ous) customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range at the time of the event.Siemens is investigating the issue.

Event Description

A discordant, falsely elevated free light chains, type lambda result was obtained on a patient sample on an atellica ch 930 analyzer using n latex flc lambda reagent.The sample was repeated for flc lambda using a 1:10 dilution, recovering lower.The undiluted sample was then rerun for flc lambda, recovering lower.The lower 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 falsely elevated flc lambda results.

Manufacturer Narrative

Siemens filed the initial mdr 9610806-2021-00075 on 14-dec-2021.Additional information (03-feb-2022): siemens healthcare diagnostics further investigated the issue.Siemens observed that the initial replicate was internally flagged as 'e521: excess antigen'.The result flag is a method specific coding which monitors the absorbance rate prior to start of the two-point reaction.If the sample absorbance rate exceeds the absorbance rate of the highest concentrated calibrator level, then the sample is flagged for having excess antigen which may impact the accuracy of the result.The method specific coding can only be observed from instrument data.The operator would only observe a result flag of 'e521: above assay range'.Siemens also observed additional 'e521: excess antigen' flagging on free light chains, type lamda (flc lambda) control replicates, which should recover within the measurement intervals.Siemens completed internal testing to verify the customer's observation.Each combination of n latex flc lambda reagent and n flc standard sl reported at least one flagged replicate which was flagged with "e521: excess antigen".Each sample tested was known to have a concentration below the measurement interval.The testing was able to replicate the observations at the customer site.Siemens is investigating the issue.

Manufacturer Narrative

Siemens filed the initial mdr 9610806-2021-00075 on 14-dec-2021.Siemens filed the first supplemental mdr 9610806-2021-00075_s1 on 28-feb-2022.Additional information (31-mar-2022): siemens healthcare diagnostics has determined that customers may experience an increased rate of flagged flc lambda quality control (qc) and patient sample results when using this assay on the atellica ch 930 analyzer.The flag message on the analyzer is >70 mg/l which indicates "> measuring interval" on the respective quality control or patient results.Typically, the error message appears when the results obtained are found to be above the defined upper measuring limit.Starting march 31, 2022, customer notification pp22-001-a-c.Us was sent to us customers and pp22-001-a-c.Ous was sent to ous customers informing customers of this issue and providing instructions to the customers.The customer notification explains the behavior described above and informs customers of actions to take to allow continued use of the assay.To date, there are no allegations of injury due to the delays.

• 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: 13001903
• MDR Text Key: 285830365
• Report Number: 9610806-2021-00075
• Device Sequence Number: 1
• Product Code: DEH
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K201496
• 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,Followup
• Report Date: 04/08/2022

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: 03/08/2022
• Device Model Number: N LATEX FLC LAMBDA
• Device Catalogue Number: 10482438
• Device Lot Number: 473260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2021
• Initial Date FDA Received: 12/14/2021
• Supplement Dates Manufacturer Received: 02/03/2022; 03/31/2022
• Supplement Dates FDA Received: 02/28/2022; 04/08/2022
• 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