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

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	12/31/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports observation of a negative advia centaur xpt hcv (ahcv) result which was discordant relative to alternate-method testing.An initial nonreactive (hcv-negative) ahcv result was obtained.Repeat testing by an alternate method produced a positive result.When the sample was tested at an external reference laboratory, another positive result was obtained.Following the positive detection of hcv rna, the sample was genotype-tested, with a result of genotype 1b, where gentotype 6 (subtypes c-l) cannot be excluded.The hcv-positive result was accepted as correct.There are no reports that treatment was altered or prescribed nor of any adverse health consequences due to the discordant ahcv result.
Additional Manufacturer Narrative
A customer from outside the united states reports observation of a negative advia centaur xpt hcv (ahcv) result which was discordant relative to alternate-method testing.An initial nonreactive (hcv-negative) ahcv result was obtained.Repeat testing by an alternate method produced a positive result.When the sample was tested at an external reference laboratory, another positive result was obtained.Following the positive detection of hcv rna, the sample was genotype-tested, with a result of genotype 1b, where gentotype 6 (subtypes c-l) cannot be excluded.The hcv-positive result was accepted as correct.There are no reports that treatment was altered or prescribed nor of any adverse health consequences due to the discordant ahcv result.In response to the report of false-negative ahcv results, siemens subjected the advia centaur xpt instrument to a comprehensive service visit, with particular attention paid to probe positions and washing functions.Vacuum, dispense volumes, dark counts (luminometer background), and resuspension and wash sequences were checked.The indexer pin was cleaned and relubricated.No major issues were found, but it was noted that cuvette-bottom positions were adjusted for three of four reagent probes, and one cracked fitting was replaced to address observed leakage from the wash block.The ahcv instructions for use (ifu) states the following, under limitations: "the advia centaur hcv assay is limited to the detection of igg antibodies to hepatitis c virus in human serum or plasma (edta, lithium or sodium heparinized plasma)." "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." "heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays.Patients routinely exposed to animals or to animal serum products can be prone to this interference and anomalous values may be observed.Additional information may be required for diagnosis." siemens is investigating.
Additional Manufacturer Narrative
Mdr 1219913-2022-00236 was initially filed on 2022-08-02.Additional information, 2022-09-13: siemens has concluded the investigation.A customer from outside the united states reported observation of a negative advia centaur xpt hcv (ahcv) result which was discordant relative to alternate-method testing.The patient's initial ahcv result was nonreactive (hcv-negative).Repeat testing by an alternate method produced a positive result, and additional testing at an external reference laboratory also produced a positive pcr result.Following the positive detection of hcv rna, the sample was genotype-tested, with a result of genotype 1b, where "genotype" 6 (subtypes c-l) cannot be excluded.In response to the report of discordant ahcv results, siemens subjected the advia centaur xpt instrument to a comprehensive service visit, which included adjustments to cuvette-bottom positions for reagent probes.As the affected samples were not re-tested following this service intervention, it is not known whether this addressed the root cause.The affected sample was not available for testing by siemens.In-house data for ahcv kit lot 412 were reviewed; all product-release specifications were met.The ahcv instructions for use (ifu) states the following, under limitations: "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." a product performance issue has not been identified.The customer is operational; no further investigation is required.Note: in section h6, the codes for investigation findings and investigation conclusion have been updated.

• Brand Name: ADVIA CENTAUR XPT HCV (AHCV)
• Common Device Name: HEPATITIS C VIRUS (ANTI-HCV) ASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; east walpole MA 02032
• Manufacturer Contact: barry ; 333 coney street; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 15148304
• Report Number: 1219913-2022-00236
• Device Sequence Number: 5671044
• Product Code: MZO
• UDI-Device Identifier: 00630414473161
• UDI-Public: 00630414473161
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 09/21/2022

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: 06/15/2022
• Device Model Number: N/A
• Device Catalogue Number: 10309061
• Device Lot Number: 412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 08/02/2022
• Supplement Report FDA Received Date: 09/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2021
• 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