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

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	10/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer reported an observation of a nonreactive advia centaur hcv (ahcv) result which was considered discordant relative to clinical expectation.Siemens healthcare diagnostics has concluded investigation of the event.Siemens evaluated the instrument data and the information provided by the customer.The calibration was valid, and quality control (qc) was performing acceptably.The 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.Return of the patient sample for investigation is not warranted, as the discordant result was not reproducible.Based on the available information, a specific cause for the discordant result was unable to be determined.A product problem was not identified.The issue was resolved by routine troubleshooting.The customer is operational, and no further action is required.
Event or Problem Description
The customer reports an observation of a non-reactive (negative) advia centaur hcv (ahcv) result which was considered discordant relative to clinical expectation.Ahcv reagent lot# 466 was in use at the time.An initial reactive (positive) result was obtained for the patient in question.The initial reactive result was not reported to the physician(s).Per advia centaur hcv (ahcv) instructions for use (ifu), the customer performed a follow-up testing with the same sample, which produced a nonreactive (negative) result.This result was considered discordant by the customer.The same sample was then repeated in duplicate which produced reactive (positive) results similar to the initial result.The reactive results were considered correct and reported to the physician(s) as it matched the clinical expectation for the affected patient.There are no known reports of patient intervention or adverse health consequences due to this event.

• Brand Name: ADVIA CENTAUR HCV
• Common Device Name: ADVIA CENTAUR HCV
• 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: 20531637
• Report Number: 1219913-2024-00452
• Device Sequence Number: 12436771
• Product Code: MZO
• UDI-Device Identifier: 00630414278759
• UDI-Public: (01)00630414278759(10)18896466(17)241021
• 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
• Report Date (Section B): 10/25/2024

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: 10/21/2024
• Device Model Number: N/A
• Device Catalogue Number: 11203483
• Device Lot Number: 18896466
• 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: 10/02/2024
• Initial Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2023
• 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: 63 YR
• Patient Sex: Female