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	05/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens healthcare diagnostics customer care center (ccc) regarding an erroneously depressed sodium (na) result on a patient sample obtained on an atellica ch 930 analyzer.Siemens is investigating the event.
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 not reported to the physician(s).The same sample was reprocessed on an alternate atellica ch 930 analyzer.A higher reprocessed result was obtained and matched the patient¿s previous history.The higher reprocessed result 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 depressed sodium (na) result.
Additional Manufacturer Narrative
Correction (18-may-2024): siemens healthcare diagnostics headquarters support center (hsc) reviewed the instrument data files.The review of the instrument data revealed that the reprocessed (correct) result for the affected sample was obtained on an alternate atellica ch 930 analyzer serial number (b)(6) as indicated in the initial mdr.Section b6 has been updated to reflect the correct information.Additional information (18-may-2024): 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.There were no integrated multisensor technology (imt) calibration errors observed.Quality control (qc) recovery was within the customer¿s expected ranges, and no issues were reported with the other patient samples, indicating that the sodium (na) assay was performing acceptably.The cause of the event is consistent with a sample integrity issue.The initial aspiration cleared the fibrin or particulates from the affected sample, and the repeat aspiration was not affected.The customer is operational.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.Initial mdr 2432235-2024-00103 was filed on 16-may-2024.

• 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.; registration # 2517506; 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: 19333259
• Report Number: 2432235-2024-00103
• Device Sequence Number: 7004220
• Product Code: CEM
• UDI-Device Identifier: 00630414596518
• UDI-Public: 00630414596518
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 05/29/2024

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: 05/08/2024
• Supplement Date Received by Manufacturer: 05/18/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 05/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown