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	07/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) 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 instrument data files and the information provided by the customer.Calibration and quality control (qc) recovery was within the customer¿s expected ranges, indicating that the sodium (na) assay was performing acceptably.Hsc concluded that the cause of the event was consistent with a sample integrity issue, due to the presence of fibrin in the sample that was aspirated on the initial aspiration, causing a decreased sample volume to be aspirated, thus causing the lower sodium recovery.The initial aspiration cleared the fibrin from the sample, and repeated aspirations were not affected.The customer 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 using an atellica ch 930 analyzer.The erroneously depressed patient result was not reported to the physician(s).The same sample was reprocessed on an alternate atellica ch 930 analyzer and the original atellica ch 930 analyzer.The reprocessed results recovered higher, matching the patient¿s history and were considered correct.The result from the alternate atellica ch 930 analyzer was reported as the correct result to the physician.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 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: linda barletta ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 19907505
• Report Number: 2432235-2024-00170
• Device Sequence Number: 7136299
• Product Code: CEM
• UDI-Device Identifier: 00630414596518
• UDI-Public: (01)00630414596518(10)140006(17)20250225
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2024

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: 02/25/2025
• Device Model Number: N/A
• Device Catalogue Number: SMN 11099315
• Device Lot Number: 140006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2024
• 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