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

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	01/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported an erroneously depressed potassium (k) result on one (1) patient sample using an a-lyte integrated multisensor (imt) obtained on an atellica ch 930 analyzer.The erroneously depressed result was not reported to the physician.The same sample was reprocessed on an alternate atellica ch 930 analyzer.A higher result was obtained, considered correct, and reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed potassium (k) result.
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding an erroneously depressed potassium (k) result on one (1) patient sample using an a-lyte integrated multisensor (imt) obtained on an atellica ch 930 analyzer.Another mdr is being filed for the same event.Siemens is investigating the event.
Additional Manufacturer Narrative
Additional information (12-mar-2025): siemens healthcare diagnostics service operations support (sos) concluded the investigation of the event.Sos evaluated the information provided by the customer and the available instrument data.Quality control (qc) was within the customer¿s acceptable ranges.The cause of the event is unknown.The customer stated the issue was resolved and no other discordant results were reported.The customer is operational.The device is performing within specifications.A potential product issue was not identified.No further evaluation is required.Section h6 has been updated to reflect the sos investigation.Initial mdr 2432235-2025-00055 was filed on 12-feb-2025.Initial mdr 2432235-2025-00054 was also filed on 12-feb-2025 for the same event.

• Brand Name: ATELLICA CH A-LYTE INTEGRATED MULTISENSOR (IMT NA K CL)
• Common Device Name: ELECTRODE, ION SPECIFIC, POTASSIUM
• 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: 21368366
• Report Number: 2432235-2025-00055
• Device Sequence Number: 18252142
• Product Code: CEM
• UDI-Device Identifier: 00630414596518
• UDI-Public: (01)00630414596518(10)140018(17)250722
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 03/25/2025

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: 07/22/2025
• Device Model Number: N/A
• Device Catalogue Number: 11099315
• Device Lot Number: 140018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2024
• 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