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

Model Number	ATELLICA CH CREATININE_2 (CREA_2)
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range and no issues were noted with other patient samples indicating that the instrument and reagents were performing acceptably.Contributing factors such as sample integrity and preanalytical variables cannot be ruled out as potential causes of the event.The cause of the event is unknown.The reagent is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
Three discordant, falsely low creatinine_2 (crea_2) results were obtained on three patient samples on an atellica ch 930 analyzer using atellica ch creatinine_2 reagent.The discordant patient results were reported to the physician(s).The samples were repeated on the same system after changing the reagent pack, recovering higher.The higher results were reported, as the correct results, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant crea_2 results.

• Brand Name: ATELLICA CH CREATININE_2 (CREA_2)
• Common Device Name: ATELLICA CH CREATININE_2 (CREA_2)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave.; tarrytown NY 10591
• Manufacturer (Section G): RANDOX LABORATORIES LTD.; registration # 8020890; 55 diamond road; crumlin co. antrim, BT29 4QY; UK BT29 4QY
• Manufacturer Contact: christopher aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 15287278
• Report Number: 2432235-2022-00242
• Device Sequence Number: 2291995
• Product Code: CGX
• UDI-Device Identifier: 00630414596457
• UDI-Public: 00630414596457
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 08/24/2022

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 Model Number: ATELLICA CH CREATININE_2 (CREA_2)
• Device Catalogue Number: 11097596
• Device Lot Number: 221630
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown