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

Catalog Number	SMN 11097521
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
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 elevated carbon dioxide, concentrated (co2_c) result obtained on a patient sample on an atellica ci 1900 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.Quality control (qc) recovered within the customer's expected ranges.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse inspected the analyzer for leaks and found no signs of leak, inspected all the probes, mixer wash basins and aligned the reagent and sample probes.Then, the cse verified the resistivity of the distilled water system feeding the analyzer and the reading was at an acceptable level.The cse performed a precision study with each level of qc which recovered acceptably.There were no issues identified by the cse with the analyzer during the visit.Based on the information provided, the cause of the event is unknown.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 elevated carbon dioxide, concentrated (co2_c) result on a patient sample on an atellica ci 1900 analyzer.The erroneous result was not reported to the physician.The same sample was reprocessed on the same atellica ci 1900 analyzer.The lower reprocessed result obtained was considered correct and reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated carbon dioxide, concentrated (co2_c) result.

• Brand Name: ATELLICA CH
• Common Device Name: ATELLICA CH CARBON DIOXIDE, CONCENTRATED (CO2_C)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; registration # 2517506; 500 gbc drive, po box 6101; 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: 20756029
• Report Number: 2432235-2024-00306
• Device Sequence Number: 15775989
• Product Code: KHS
• UDI-Device Identifier: 00630414595900
• UDI-Public: (01)00630414595900(10)130494(17)241217
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 11/22/2024

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: 12/17/2024
• Device Catalogue Number: SMN 11097521
• Device Lot Number: 130494
• 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: 10/29/2024
• Initial Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2023
• 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