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	01/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Eight (8) discordant falsely elevated carbon dioxide, concentrated (co2_c) results on seven (7) patient samples were obtained on an atellica ch 930 analyzer.The falsely elevated results were not reported to the physician(s).The same samples were reprocessed on the same atellica ch 930 analyzer.Lower results, considered correct, were obtained and reported.There are no known reports of patient intervention and adverse health consequences due to the falsely elevated carbon dioxide, concentrated (co2_c) results.
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding eight (8) falsely elevated carbon dioxide, concentrated (co2_c) results on seven (7) patient samples obtained on an atellica ch 930 analyzer.Quality control (qc) recovered within the customer¿s expected ranges on the event date.Siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the information provided by the customer and the instrument data files.The hsc review of the instrument data files showed that a co2_c reagent well exhibited atypical performance.Calibrations performed on that reagent well had much higher than typical milli-absorbance units (signal) on the level 2 calibrator.When the analyzer began using a new reagent well, it did not perform in the same manner as the previous well, which generated the falsely elevated patient results.The customer discarded the co2_c reagent pack as part of standard troubleshooting and performed a lot calibration on a new co2_c reagent pack.Hsc determined that co2_c reagent well was contaminated.There was no hardware issue observed with the atellica ch 930 analyzer.Hsc concluded that the investigation of the event is consistent with a contaminated well of co2_c reagent, which generated an inaccurate lot calibration, and the source of the contamination is unknown.The cause of the event is unknown.The analyzer is fully operational.The device is performing within specifications.No further evaluation is required.

• 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: linda barletta ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 18622266
• Report Number: 2432235-2024-00021
• Device Sequence Number: 2466357
• Product Code: KHS
• UDI-Device Identifier: 00630414595900
• UDI-Public: 00630414595900
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 02/01/2024

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: 06/04/2024
• Device Model Number: N/A
• Device Catalogue Number: SMN 11097521
• Device Lot Number: 130219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2023
• 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