MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH; ATELLICA CH CARBON DIOXIDE, CONCENTRATED (CO2_C)

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	06/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding erroneously elevated carbon dioxide, concentrated (co2_c) results on four (4) patient samples obtained on an atellica ch 930 analyzer.Siemens is investigating the event.
Event or Problem Description
The customer reported to siemens that they obtained erroneously elevated carbon dioxide, concentrated (co2_c) results on four (4) patient samples on an atellica ch 930 analyzer.The erroneously elevated results were reported to the physician(s), and the results were questioned.The same samples were reprocessed on the original atellica ch 930 analyzer.Lower reprocessed results were obtained and considered correct.Corrected reports were issued.There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated carbon dioxide, concentrated (co2_c) results.
Additional Manufacturer Narrative
Correction (02-jul-2024): siemens healthcare diagnostics headquarters support center (hsc) reviewed the instrument data files.Upon reviewing the instrument data, it was identified that four (4) additional erroneously elevated carbon dioxide, concentrated (co2_c) results on the same four (4) patient samples were obtained on the event date when the samples were reprocessed on the original atellica ch 930 analyzer.Section b6 has been updated to reflect the correct information.Additional information (02-jul-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.Hsc reviewed the aspiration of reagents and samples and observed no atypical patterns.No issues were observed with the atellica ch 930 analyzer and no issues were observed with the co2 reagent.The cause of the event is unknown.The analyzer 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 2432235-2024-00146 was filed on 02-jul-2024.

• Brand Name: ATELLICA CH
• Common Device Name: ATELLICA CH CARBON DIOXIDE, CONCENTRATED (CO2_C)
• 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: 19654454
• Report Number: 2432235-2024-00146
• Device Sequence Number: 6596500
• Product Code: KHS
• UDI-Device Identifier: 00630414595900
• UDI-Public: 00630414595900
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K100289
• 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,Followup
• Report Date (Section B): 07/24/2024

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: 10/01/2024
• Device Model Number: N/A
• Device Catalogue Number: SMN 11097521
• Device Lot Number: 130399
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2023
• 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