MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT HCV (AHCV) IMMUNOASSAY; HEPATITIS C VIRUS (ANTI-HCV) ASSAY,

Model Number	N/A
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthcare diagnostics is investigating.The instructions for use states in the interpretation of results section: "samples with a calculated value greater than or equal to 1.00 index value are considered reactive for igg antibodies to hcv.Supplemental testing of the sample is recommended." the instructions for use states in the limitations section: "the results from this or any other diagnostic kit should be used and interpreted only in the context of the overall clinical picture.A negative test result does not exclude the possibility of exposure to hepatitis c virus.".
Event or Problem Description
A false negative result was obtained using advia centaur xpt hcv (ahcv) immunoassay.An initial positive result was obtained using advia centaur xpt hcv (ahcv).The customer reran the sample per their laboratory policy on the same instrument on the same day with the same sample.The instrument tested the sample in duplicate, which resulted in a positive and a negative result.Both rerun results were uploaded to the lis.The result provided to physician was "non-reactive".The customer filled out a corrected report including the positive and negative results and submitted it to physician.The customer believes the positive result to be correct.Patient treatment was not altered or prescribed.There was no report of adverse health consequences due to the discordant hcv result.
Additional Manufacturer Narrative
Siemens filed initial mdr on june 3, 2020.Additional information from 07/13/2020: siemens reviewed the instrument and event data.It was found, based on the feedback provided, that the customer failed to follow the documented instructions for use (ifu).Customer should have allowed the system to report the initially reactive result and not repeated the testing.Initially reactive results should be reported as reactive per the instructions for use (ifu) 11203493_en rev.C, 2019-12, assay for the detection of immunoglobulin g (igg) antibodies to hepatitis c virus.The customer was educated on the proper handling of initially reactive results per the ifu, and the issue was considered resolved with the troubleshooting provided.Based on the investigation, no product problem was identified.The system is operating as expected.No further investigation is required.The result and conclusion codes have been updated to reflect the investigation results.Reference section h6 of this report for the updated codes.

• Brand Name: ADVIA CENTAUR XPT HCV (AHCV) IMMUNOASSAY
• Common Device Name: HEPATITIS C VIRUS (ANTI-HCV) ASSAY,
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 10115591
• Report Number: 1219913-2020-00132
• Device Sequence Number: 11603305
• Product Code: MZO
• UDI-Device Identifier: 00630414473161
• UDI-Public: 00630414473161
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2020

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 Model Number: N/A
• Device Catalogue Number: 10309061
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/11/2020
• Supplement Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 06/03/2020
• Supplement Report FDA Received Date: 08/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR