MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR CA 15-3; SYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR

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	10/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer notified siemens of discordant low patient results with advia centaur xp ca 15-3, lot 217 calibrated with c4376.The issue was identified during routine troubleshooting with the customer for out-of-range quality control (qc), when the patient samples tested before the qc issue were retested when qc was back in range.The patient retest results were higher than the initial results and were considered correct.The initial depressed patient results were reported to the physicians, but not questioned.Corrected reports were issued to the physicians using the higher retest results.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with this event.
Additional Manufacturer Narrative
This incident occurred in the united states (us).The us customer reported an observation of discordant low patient results with advia centaur xp ca 15-3, lot 217 that were higher upon retesting.The issue was identified during routine troubleshooting with the customer for out-of-range quality control (qc).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 investigating.
Additional Manufacturer Narrative
Siemens investigated a us customer report of depressed advia centaur xp ca 15-3, lot 217 results.The issue was identified during routine troubleshooting with the customer for out-of-range quality control (qc).There have been no allegations of patient harm, changes in treatment, or delays of diagnosis in association with this event.Siemens requested information and recommended troubleshooting actions, but the customer has declined to provide any additional information regarding this event.Based on the limited information provided further evaluation is not possible.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.".

• Brand Name: ADVIA CENTAUR CA 15-3
• 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: 20662206
• Report Number: 1219913-2024-00466
• Device Sequence Number: 12819819
• Product Code: MOI
• UDI-Device Identifier: 00630414461311
• UDI-Public: (01)00630414461311(10)42506217(17)250207
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K012357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 03/26/2025

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: 02/07/2025
• Device Model Number: N/A
• Device Catalogue Number: 10327620
• Device Lot Number: 42506217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2024
• 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