MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR HCV (AHCV); ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS

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	10/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside the united states reported observation of a nonreactive advia centaur hcv (ahcv) result which was discordant relative to patient history and alternate-method testing.The ahcv 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.¿ the following is stated under limitations: ¿patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results.This assay is designed to minimize interference from heterophilic antibodies.¿ siemens is investigating.
Event or Problem Description
The customer reports observation of a nonreactive advia centaur hcv (ahcv) result which was discordant relative to patient history and alternate-method testing.Ahcv reagent lot 445 was in use at the time.A nonreactive (negative) ahcv result was obtained for a patient with a history of positive hcv results since 2018.This negative result was not reported to the physician, and an additional test was performed using an alternate method.The alternate method produced a positive result, which was accepted as correct.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with the observed discordance.
Additional Manufacturer Narrative
Mdr 1219913-2023-00290 was initially submitted on 2023-11-14.A customer from outside the united states observation of a nonreactive advia centaur hcv (ahcv) result which was discordant relative to patient history and alternate-method testing.Siemens investigated reagent, instrument, and sample data, and did not identify any underlying issues.Reagent and instrument problems were ruled out, as quality control (qc) results were within expected ranges, and no issues were identified with any other patient samples.Based on the available information, the specific cause of the discordant observation cannot be definitively determined.But a sample-specific interference could be responsible, or the result could be representative of normal assay performance.No product problem was identified.The customer is operational, and no further action is required.

• Brand Name: ADVIA CENTAUR HCV (AHCV)
• Common Device Name: ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; east walpole MA 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 18134238
• Report Number: 1219913-2023-00290
• Device Sequence Number: 7753363
• Product Code: MZO
• UDI-Device Identifier: 00630414473161
• UDI-Public: 00630414473161
• 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): Unknown
• 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): 12/21/2023

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: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 10309061
• Device Lot Number: 445
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2023
• Supplement Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2023
• 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 Sex: Unknown