Model Number N LATEX FLC LAMBDA |
Device Problem
Low Test Results (2458)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/06/2022 |
Event Type
malfunction
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Manufacturer Narrative
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An outside of the united states 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.Mdr 9610806-2023-00002 was filed for the discordant flc lambda results obtained on the bn ii system using n latex flc lambda reagent (lot: 473271).
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Event Description
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A falsely low free light chains, type lambda (flc lambda) result was obtained on a bn ii system using n latex flc lambda reagent.The sample was repeated on the bn ii system using a 1:100 and 1:2000 sample dilution, again recovering falsely low.The sample was then run for flc lambda on an atellica neph 630 system using an alternate lot of n latex flc lambda reagent, recovering falsely low.None of the discordant results were reported to the physician(s).The sample was then repeated for flc lambda on the atellica neph 630 system using a non-siemens reagent, recovering higher.The higher result matched the patient's electrophoresis result and 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 low flc lambda results.
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Manufacturer Narrative
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Siemens filed the initial mdr 9610806-2023-00003 on 20-jan-2023.Additional information (27-jan-2023): the affected sample was provided for analysis.It was determined that the sample contained a highly dimerized free light chain, type lambda (flc lambda) molecule.In some patients, flc lambda is skewed towards dimerization, causing the falsely depressed flc lambda results.After reduction of the inter-chain di-sulfide bridges during further investigation, the flc lambda concentration was found to be above the reference interval and comparable to the result obtained using the non-siemens reagent.The reagent is performing according to specifications.No further evaluation of this device is required.Mdr 9610806-2023-00002_s1 was also filed for the incident.
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Search Alerts/Recalls
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