MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH; ATELLICA CH 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	05/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to siemens that they obtained an erroneously depressed creatinine_2 (crea_2) patient sample result on an atellica ch 930 analyzer.The initial erroneous result was not reported to the physician(s).The same sample was reprocessed on the original atellica ch 930 analyzer.The reprocessed result recovered higher, matched the clinical history and was reported as the correct result to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed creatinine_2 (crea_2) result.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens customer care center (ccc) regarding an erroneously depressed creatinin_2 (crea_2) result obtained on a patient sample on an atellica ch 930 analyzer.Siemens healthcare diagnostics headquarters support center (hsc) reviewed the information provided by the customer and queried the instrument data.The customer was unable to provide details regarding the sample.Hsc was unable to provide further evaluation due to insufficient information provided for the sample.The cause of the event is unknown.The device is performing within specifications.No further evaluation is required.

• Brand Name: ATELLICA CH
• Common Device Name: ATELLICA CH CREATININE_2 (CREA_2)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue,; tarrytown NY 10591
• Manufacturer (Section G): RANDOX LABORATORIES LTD.; 55 diamond road; crumlin,; co. antrim 19714 -610; UK 19714-6101
• Manufacturer Contact: eiman sulieman ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 19566091
• Report Number: 2432235-2024-00140
• Device Sequence Number: 20573760
• Product Code: CGX
• UDI-Device Identifier: 00630414596457
• UDI-Public: 00630414596457
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 06/19/2024

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: SMN 11097596
• Device Lot Number: 232081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2024
• Initial Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 68 YR
• Patient Sex: Male