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

Model Number N/A

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/18/2024

Event Type  malfunction  

Manufacturer Narrative

A united states customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding a falsely elevated carbon dioxide, concentrated (co2_c) result obtained on a patient sample on an atellica ® ci 1900 analyzer.Siemens is investigating the event.

Event Description

A falsely elevated carbon dioxide, concentrated (co2_c) patient sample result was obtained on an atellica ® ci 1900 analyzer.The falsely elevated patient sample result was not reported to the physician.The same sample was reprocessed on the same atellica ® ci 1900 analyzer and a lower result was obtained.The lower result was considered correct.The anion gap was acceptable, and the lower result was reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the falsely elevated carbon dioxide, concentrated (co2_c) result.

Manufacturer Narrative

Additional information (17-may-2024): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc evaluated the information provided from the available data logs.A customer service engineer (cse) performed routine service tasks on the atellica ci 1900 analyzer.No discordant results were reported after these routine service tasks were completed during multiple visits.The cause of the event is unknown.A potential product issue was not identified.The customer is operational.Correction (20-may-2024): this is a correction to the sample id in section b6 for the reprocessed result.The correct sample id is (b)(6).Section b6 has been updated.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.Initial mdr 2432235-2024-00084 was filed on 26-april-2024.

• Brand Name: ATELLICA CH CARBON DIOXIDE, CONCENTRATED (CO2_C)
• Type of Device: 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.; 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: 19195886
• MDR Text Key: 341483819
• Report Number: 2432235-2024-00084
• Device Sequence Number: 1
• Product Code: KHS
• UDI-Device Identifier: 00630414595900
• UDI-Public: 00630414595900
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/21/2024

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 11097521
• Device Lot Number: 130494
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2024
• Initial Date FDA Received: 04/26/2024
• Supplement Dates Manufacturer Received: 05/10/2024
• Supplement Dates FDA Received: 05/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Male