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	12/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer reported observation of a nonreactive (negative) atellica im hcv (ahcv) result which was 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 the event.
Event or Problem Description
The customer reports observation of a nonreactive (negative) advia centaur hcv (ahcv) result which was discordant relative to repeat testing.Ahcv reagent lot#: 473 was in use at the time.An initial reactive (positive) result was obtained for the patient in question.The same sample was retested on the same analyzer and obtained a nonreactive (negative) result.Both results were not reported to the physician(s).The nonreactive (negative) result was considered discordant by the customer.Therefore, a follow-up testing was performed for the same sample in duplicate which produced reactive (positive) results.The reactive (positive) results were considered correct and reported to the physician(s).There is no known reports of patient intervention or adverse health consequences due to this event.
Additional Manufacturer Narrative
Mdr 1219913-2025-00001 was initially filed on 03-jan-2025.Additional information (24-jan-2025): siemens healthcare diagnostics has concluded the investigation of the event.Siemens investigated the customer report of false negative results for the ahcv assay when using insert cups for sample processing, while no issues were observed with the automation line.Siemens evaluated the instrument data and the information provided by the customer.It was noted that the discordant results were reported only when the customer use insert cups (ezee nest 13mm cups) for samples in the front load and there were no issues when using primary tubes in both the automation line and the front load line.Service was dispatched to the customer site.Siemens customer service engineer (cse) verified the sample tube settings in the system menu, checked the sample probe alignments to the tube to ensure that the insert cups had sufficient sample volume and placed them in the correct tube holder for proper aspiration.The cse inspected the system and performed routine troubleshooting and system maintenance.Following this routine troubleshooting intervention, quality control (qc) results recovered acceptably, and no further sample outliers were identified.The issue was resolved by routine troubleshooting.A product problem has not been identified.Customer is operational; no further actions are required.Note: in section h6, codes for investigation findings and investigation conclusions were 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: mekala g ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 840457474
• MDR Report Key: 21065826
• Report Number: 1219913-2025-00001
• Device Sequence Number: 3417632
• Product Code: MZO
• UDI-Device Identifier: 00630414278759
• UDI-Public: (01)00630414278759(10)86234473(17)250507
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2025

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: 05/07/2025
• Device Model Number: N/A
• Device Catalogue Number: 11203483
• Device Lot Number: 86234473
• 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: 12/10/2024
• Supplement Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2024
• 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