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

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	09/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted a siemens customer care center regarding an erroneous depressed carbon dioxide, concentrated (co2_c) patient sample results obtained on an atellica ch 930 analyzer.Service operations support (sos) team (formerly headquarter support center (hsc)) concluded the investigation of the event.Sos reviewed the instrument data and found the erroneous depressed result was from a particular reagent pack.Quality control (qc) was out of lab ranges.The customer used a new reagent pack and both qc and patient sample results were acceptable.Sos concluded the cause of the event is consistent with a damaged seal, that was not apparent and allowed exposure to carbon dioxide.A potential product issue was not identified.The customer is operational.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
The customer reported erroneous depressed carbon dioxide, concentrated (co2_c) patient sample results were obtained on an atellica ch 930 analyzer.It is unknown if the erroneous results were reported to the physician(s).The same samples were reprocessed on an alternate atellica ch 930 analyzer.The higher reprocessed results obtained were considered correct and reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the erroneous depressed carbon dioxide, concentrated (co2_c) results.

• Brand Name: ATELLICA CH CARBON DIOXIDE, CONCENTRATED (CO2_C)
• Common Device Name: ENZYMATIC, CARBON-DIOXIDE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive po box 6101; registration # 2517506; newark DE 19714 6101
• Manufacturer Contact: eiman sulieman ; 500 gbc drive; po box 6101; newark, DE 19714-6101 ; 7372808688
• MDR Report Key: 20631048
• Report Number: 2432235-2024-00289
• Device Sequence Number: 7909613
• Product Code: KHS
• UDI-Device Identifier: 00630414595900
• UDI-Public: (01)00630414595900(10)130494(17)241217
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K100289
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/07/2024

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 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2023
• 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