MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR BR; SYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR

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	08/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer reported observation of elevated advia centaur br results with lot # 271 for multiple patient samples which were considered discordant relative to repeat testing.The assay's instructions for use (ifu) states the following, under interpretation of results: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens is evaluating this issue.
Event or Problem Description
The customer reports an observation of elevated advia centaur br results with lot # 271 for multiple patient samples which were considered discordant relative to repeat testing.Customer provided example data for elevated advia centaur br results from 07-aug-2024.The initial discordant elevated results were reported to the physician, who questioned the results.Therefore, the same samples were repeated on an alternate advia centaur xp instrument and obtained much lower results when compared to the initial elevated results.The lower results were considered correct based on the clinical picture of these patients.These results were reported as correct results to the physician(s).There are no allegations of patient harm, changes in treatment, or delays of diagnosis or treatment resulting from the observed result discordance.
Additional Manufacturer Narrative
Mdr 1219913-2024-00399 was initially filed on 03-sep-2024.Additional information 17-sep-2024: siemens has concluded the investigation for the issue reported by a united states (us) customer regarding observation of elevated advia centaur br results with lot # 271 for patient samples which were considered discordant relative to repeat testing.Siemens customer service engineer (cse) was dispatched to the account.Siemens evaluated the advia centaur xp system, calibration, and quality control (qc) data which showed elevated qc results.Advia centaur xp system was evaluated; no instrument problems were noted.Cse recommended to calibrate lot # 271 and calibration and qc results were acceptable.The customer has not reported any recurrence of the issue post cse visit.Based on the available information, the cause of the not reproducible elevated results could not be determined.The customer is operational, and no further action is required.Note: in section h6, the codes for investigation findings and investigation conclusions have been updated.

• Brand Name: ADVIA CENTAUR BR
• Common Device Name: SYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; registration #1219913; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032
• MDR Report Key: 20125733
• Report Number: 1219913-2024-00399
• Device Sequence Number: 16960267
• Product Code: MOI
• UDI-Device Identifier: 00630414204772
• UDI-Public: (01)00630414204772(10)60973271(17)250326
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K982680
• 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,Followup
• Report Date (Section B): 10/01/2024

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: 03/26/2025
• Device Model Number: N/A
• Device Catalogue Number: 10340081
• Device Lot Number: 60973271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2024
• 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