MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH; ATELLICA CH A-LYTE INTEGRATED MULTISENSOR (IMT NA K CL)

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding an erroneously depressed sodium(na) result on a patient sample obtained on an atellica ch 930 analyzer.Siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the information provided by the customer and the instrument data files.Quality control (qc) recovered within the customer¿s expected ranges.The aspiration profiles of the dilution probe of this sample shows slight irregularities in its aspiration profile.No other discordant results were reported by the customer or observed during data review suggesting the issue is isolated to this sample.The probable cause of the event is sample specific due to the presence of gel, fibrin, micro-clots, and/or cellular debris that impacted the sample aspiration.The instrument is operational.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
The customer reported to siemens that they obtained an erroneously depressed sodium (na) result on a patient sample on an atellica ch 930 analyzer.The erroneously depressed result was reported to the physician(s) and the result was questioned.The same sample was reprocessed on two (2) alternate atellica ch 930 analyzers and higher results were obtained.The reprocessed results obtained were consistent and considered correct.No corrected report was issued.There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed sodium (na) result.

• Brand Name: ATELLICA CH
• Common Device Name: ATELLICA CH A-LYTE INTEGRATED MULTISENSOR (IMT NA K CL)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive, po box 6101; registration # 2517506; newark DE 19714 6101
• Manufacturer Contact: linda barletta ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 19280333
• Report Number: 2432235-2024-00094
• Device Sequence Number: 17732186
• Product Code: CEM
• UDI-Device Identifier: 00630414596518
• UDI-Public: 00630414596518
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K222438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/09/2024

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 Expiration Date: 08/20/2024
• Device Model Number: N/A
• Device Catalogue Number: SMN 11099315
• Device Lot Number: 130012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2023
• 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 Age: 80 YR
• Patient Sex: Male