MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR SYPHILIS (SYPH)

Model Number	N/A
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens remote services center (rsc) and reported an observation of a false negative (non-reactive) advia centaur syphilis (syph) result, which was discordant relative to repeat testing on an alternate method.Siemens is evaluating the event.
Event or Problem Description
The customer reports an observation of a false negative (non-reactive) advia centaur xp syphilis (syph) result for a patient sample, which was discordant relative to repeat testing.An initial non-reactive result was obtained for a 49-year-old female patient.This initial result was reported to the physician(s) and questioned.The sample was repeated on the original advia centaur analyzer and obtained a similar non-reactive result.The sample was then tested on an alternate method and obtained a reactive (positive) result, which was considered correct and reported to the physician(s).For troubleshooting purpose, the same sample was repeated on an alternate atellica im analyzer and a reactive result was obtained.T.Pallidum particle agglutination [tppa] and rapid plasma reagin (rpr) results on this sample were also reactive.There are no allegations of patient harm, changes in treatment, or delays in diagnosis in association with the observed result discordance.
Additional Manufacturer Narrative
Mdr 1219913-2025-00213 was initially filed on 27-nov-2025.Additional information (11-dec-2025): siemens healthcare diagnostics has concluded the investigation of the event.An outside of the united states (ous) customer contacted the siemens remote services center (rsc) and reported an observation of a non-reactive (positive) advia centaur syphilis (syph) result, which was considered discordant relative to repeat testing on an alternate method.Siemens evaluated the instrument data and the information provided by the customer.Quality control (qc) showed recovery within acceptable ranges, and no issues were reported with other patient samples.A review of the reagent release data for advia centaur syph lot 112 confirmed that it met all manufacturer specifications for release.A review of global peer data on patient reactive and non-reactive rates for advia centaur and atellica im syph lot 112 reveals no differences from other reagent lots.It is unknown if the patient has been diagnosed with yaws, pinta, or leptospirosis.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 SYPHILIS (SYPH)
• Common Device Name: ADVIA CENTAUR SYPHILIS (SYPH)
• 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: 23665784
• Report Number: 1219913-2025-00213
• Device Sequence Number: 21060442
• Product Code: LIP
• UDI-Device Identifier: 00630414580173
• UDI-Public: (01)00630414580173(10)53262112(17)260524
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K112343
• 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): 12/24/2025

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: 05/24/2026
• Device Model Number: N/A
• Device Catalogue Number: 10492493
• Device Lot Number: 53262112
• 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: 11/17/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 11/27/2025
• Supplement Report FDA Received Date: 12/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/24/2025
• 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: 49 YR
• Patient Sex: Female