MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR HCV (AHCV)

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	07/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside of the united states (ous) reported an observation of non-reactive (negative) advia centaur antibodies to hepatitis c virus (ahcv) results obtained on a patient sample, which were discordant relative to repeat testing on an alternate method.Calibration was acceptable, and quality control (qc) recovered within the laboratory established ranges on the event date(s).The limitations section of the assay instructions for use (ifu) states, "a negative test result does not exclude the possibility of exposure to or infection with hcv.Hcv antibodies may be undetectable in some stages of the infection and in some clinical conditions." siemens is evaluating the event.
Event or Problem Description
The customer reported an observation of non-reactive (negative) advia centaur antibodies to hepatitis c virus (ahcv) results obtained on a patient sample, which were discordant relative to repeat testing on an alternate method.The initial non-reactive (negative) result was not reported to the physician(s).The sample was retested on (b)(6) 2025 using an alternate method and obtained a similar non-reactive (negative) result, which was considered discordant.On the following day, the sample was again retested on an advia centaur xp system and obtained a similar non-reactive (negative) result, which was considered discordant.Subsequently, the sample was retested using another alternate method and obtained a reactive (positive) result, which was considered correct.Due to insufficient sample volume, the customer did not perform further testing, including a molecular biology test.No ahcv results were reported to the physician(s) for this patient.The laboratory has requested collection of a new sample, depending upon the patient's return.There are no allegations of patient harm, changes in treatment, or delays of diagnosis or treatment in association with the observed result(s) discordance.
Additional Manufacturer Narrative
Mdr 1219913-2025-00149 was initially filed on 28-jul-2025.Mdr 1219913-2025-00148 was initially filed on 28-jul-2025 for the event dated 27-jun-2025.The section b5 of the initial mdr stated that "the laboratory has requested collection of a new sample, depending upon the patient's return".However, the customer did not provide any further information.Additional information (26-aug-2025): siemens concluded the investigation of an outside of the united states (ous) customer complaint regarding an observation of non-reactive (negative) advia centaur antibodies to hepatitis c virus (ahcv) results obtained on a patient sample, which were discordant relative to repeat testing on an alternate method.Siemens evaluated the available instrument data, and the information provided by the customer.Reagent and instrument issues were ruled out based on quality control (qc) recovery and calibration were within acceptable ranges.The affected sample was not returned to siemens for further evaluation.Based on the available information, the cause of the discordant results was unable to be determined and the issue was isolated to the affected patient sample.A product problem was not identified.The customer is operational.Note: in section h6, the codes for investigation findings and investigation conclusions have been updated.

• Brand Name: ADVIA CENTAUR HCV (AHCV)
• Common Device Name: ADVIA CENTAUR HCV (AHCV)
• 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: 22636702
• Report Number: 1219913-2025-00149
• Device Sequence Number: 9074315
• Product Code: MZO
• UDI-Device Identifier: 00630414473161
• UDI-Public: (01)00630414473161(10)92243479(17)260103
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P030056
• 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): 09/17/2025

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: 01/03/2026
• Device Model Number: N/A
• Device Catalogue Number: 10309061
• Device Lot Number: 92243479
• 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: 07/03/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/03/2025
• 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: 77 YR
• Patient Sex: Female