MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH 930 ANALYZER

Model Number	ATELLICA CH 930 ANALYZER
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted siemens to report that one falsely elevated carbon dioxide (co2_c) test result for one patient sample was obtained from an atellica ch 930 analyzer.The customer indicated that between 90 and 100 patient samples may have been impacted.The customer stated test results were both falsely elevated and falsely depressed.The customer provided only one example of a discordant result.The customer stated they were having a problem with the evoqua water purification system.Evoqua is not a siemens product.A siemens customer service engineer (cse) was dispatched to the customer site to inspect the analyzer.The cse performed routine maintenance on the analyzer but did not resolve the issue.The cse followed up with the customer after the evoqua water purification system was serviced.The customer stated that quality control results were acceptable after the evoqua water purification system was serviced.Siemens evaluated the available information, including a review of the co2_c calibrations, and found the calibrations performed near the time of the event had atypical signal responses and calibration coefficients which directly relate to poor water quality.The cause of the falsely elevated carbon dioxide (co2_c) test result was the laboratory's water purification system.The analyzer is performing within specifications.No further evaluation of this analyzer is needed.
Event or Problem Description
Multiple discordant concentrated carbon dioxide (co2_c) patient test results were obtained from an atellica ch 930 analyzer.The customer provided only one example of a falsely elevated carbon dioxide (co2_c) test result for one patient sample.The initial test result was reported to the physician(s).The same sample was repeated on the same analyzer.The repeat test 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 event.

• Brand Name: ATELLICA CH 930 ANALYZER
• Common Device Name: ATELLICA CH 930 ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; flanders NJ 07836
• Manufacturer Contact: karl aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9142550572
• MDR Report Key: 15843404
• Report Number: 2432235-2022-00303
• Device Sequence Number: 20328989
• Product Code: JJE
• UDI-Device Identifier: 00630414595900
• UDI-Public: 00630414595900
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K151767
• 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): 11/22/2022

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 Model Number: ATELLICA CH 930 ANALYZER
• Device Catalogue Number: 11067000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2022
• Initial Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown