MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT TOXOPLASMA G (TOXO G)

Model Number	N/A
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported an observation of a reactive (positive) advia centaur toxoplasma g (toxo g) result which was considered discordant relative to repeat testing when using reagent lot#296.An initial reactive result was obtained on a patient sample.The reactive result was reported to the physician, who questioned the result.The same sample was repeated on the original advia centaur xpt instrument and obtained a non-reactive (negative result).The non-reactive result was considered correct and issued on the corrected report to the physician.There are no known reports of delay, patient intervention, or adverse health consequences due to this event.
Additional Manufacturer Narrative
A customer from outside the united states (ous) reported observation of a reactive (positive) advia centaur toxoplasma igg (toxo g) result which was discordant relative to repeat testing.Siemens is evaluating this issue.
Additional Manufacturer Narrative
Mdr 1219913-2025-00122 was initially filed on 24-jun-2025.Additional information (27-jun-2025): siemens healthcare diagnostics has concluded the investigation of the event.A customer from outside the united states (ous) reported observation of a reactive (positive) advia centaur toxoplasma igg (toxo g) result, which was discordant relative to repeat testing.Siemens evaluated the instrument data and the information provided by the customer.Siemens reviewed the customer's calibration data and internal quality control (qc).Calibration was valid, and the qc recovered acceptably.Reagent issues were ruled out based on review of qc which showed recovery within acceptable ranges and no issues were reported with other patient samples.Siemens analyzed interpretation rates on advia centaur xp/xpt toxo g and atellica im toxo g for lot 296 and showed consistent rates across both systems.The customer¿s calculated specificity for lot 296 was 99.96% compared to 98.6% in the instructions for use (ifu).Based on the available information, the cause of the discordant result cannot be determined.A product problem has not been identified.The customer is operational, and the reported issue was resolved by routine troubleshooting.Note: in section h6, the codes for investigation findings and investigation conclusions have been updated.

• Brand Name: ADVIA CENTAUR XPT TOXOPLASMA G (TOXO G)
• Common Device Name: ADVIA CENTAUR XPT TOXOPLASMA G (TOXO G)
• 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: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 22317771
• Report Number: 1219913-2025-00122
• Device Sequence Number: 15709146
• Product Code: LGD
• UDI-Device Identifier: 00630414208459
• UDI-Public: (01)00630414208459(10)26022296(17)250801
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K012183
• 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): 07/24/2025

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: 08/01/2025
• Device Model Number: N/A
• Device Catalogue Number: 10310321
• Device Lot Number: 26022296
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2025
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2024
• 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 Age: 38 YR
• Patient Sex: Female