MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH CREATININE_2; CREATININE_2 (CREA_2)

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	02/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A falsely depressed creatinine_2 (crea_2) patient sample result was obtained on an atellica ® ch 930 analyzer compared to repeat testing.The falsely depressed patient result was reported to the physician and questioned.The same sample was reprocessed on the same atellica ® ch 930 analyzer.On 27-feb-2024 the same sample was reprocessed on an alternate atellica ® ch 930 analyzer and resulted higher.The higher results were considered correct and reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the falsely depressed creatinine_2 (crea_2) result.
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding a falsely depressed creatinine_2 (crea_2) result obtained on an atellica ® ch 930 analyzer.Siemens is investigating the event.
Additional Manufacturer Narrative
Additional information (15-march-2024): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the information provided by the customer.Quality control recovered within the customer's acceptable ranges.Siemens service performed standard troubleshooting actions and confirmed the system met specifications.The cause of the event is unknown.A potential product issue was not identified.The customer 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 2432235-2024-00048 was filed on 11-march-2024.

• Brand Name: ATELLICA CH CREATININE_2
• Common Device Name: CREATININE_2 (CREA_2)
• 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: 18875044
• Report Number: 2432235-2024-00048
• Device Sequence Number: 7839119
• Product Code: CGX
• UDI-Device Identifier: 00630414596457
• UDI-Public: 00630414596457
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K161494
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2024

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: 01/01/2025
• Device Model Number: N/A
• Device Catalogue Number: 11097596
• Device Lot Number: 232081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/28/2024
• Supplement Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2023
• 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: Female