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	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Through the review of instrument data, siemens identified an erroneously elevated sodium (na) result on a patient sample obtained on an atellica ch 930 analyzer.Siemens reviewed the information provided by the customer and the instrument data logs.Siemens concluded that the cause of the event was consistent with the insufficient integrated multisensor technology (imt) diluent, resulting in improper imt sample dilutions most likely due to imt diluent consumable not being seated properly.The customer is operational.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
Through the review of instrument data, siemens identified an erroneously elevated sodium (na) result obtained on a patient sample on an atellica ch 930 analyzer.The initial result was not reported to the physician.The same sample was reprocessed on an alternate atellica ch 930 analyzer.The reprocessed result recovered lower than the initial 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 erroneously elevated 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 avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive, po box 6101; registration # 2517506; newark DE 19714 6101
• Manufacturer Contact: mekala g ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 840457474
• MDR Report Key: 21053736
• Report Number: 2432235-2025-00002
• Device Sequence Number: 8775422
• Product Code: CEM
• UDI-Device Identifier: 00630414596518
• UDI-Public: (01)00630414596518(10)140009(17)250408
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/02/2025

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: 04/08/2025
• Device Model Number: N/A
• Device Catalogue Number: SMN 11099315
• Device Lot Number: 140009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2024
• 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