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

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	11/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported an erroneously depressed patient sample result with sodium (na) was obtained on an atellica ® ch 930 analyzer.The erroneously depressed patient sample result was not reported to the physician.The same sample was reprocessed on an abl radiometer (blood gas analyzer).A higher result was obtained, considered correct and reported to the physician.The same sample was reprocessed on an alternate atellica ® ch 930 analyzer.A similar erroneous patient result was obtained as on the original atellica ® ch 930 analyzer.There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed sodium (na) result.
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding an erroneously depressed patient sample result with sodium (na) on an atellica ® ch 930 analyzer.Siemens is investigating the event.
Additional Manufacturer Narrative
Siemens healthcare diagnostics service operations support (sos) concluded the investigation of the event.Sos reviewed the information provided by the customer.Quality control (qc) recovered within the customer's acceptable ranges.No reagent nor instrument issues were identified.The cause of the event is unknown.A potential product issue was not identified.The customer is operational.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the sos investigation.Section g4 has been revised with the correct 510k number.Section d2a has been revised with the correct product code.Initial mdr was filed on 05-dec-2024.

• Brand Name: ATELLICA CH A-LYTE INTEGRATED MULTISENSOR (IMT NA K CL)
• Common Device Name: ELECTRODE, ION SPECIFIC, SODIUM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer Contact: linda barletta ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 20856198
• Report Number: 2432235-2024-00337
• Device Sequence Number: 8622614
• Product Code: JGS
• UDI-Device Identifier: 00630414596518
• UDI-Public: (01)00630414596518(10)140008(17)250401
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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,Followup
• Report Date (Section B): 01/10/2025

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: 04/01/2025
• Device Model Number: N/A
• Device Catalogue Number: 11099315
• Device Lot Number: 140008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/10/2024
• 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