MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM HEPATITIS C (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	07/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside the united states reported observation of a false negative atellica im hepatitis c (ahcv) result.Assay calibration was valid, and no issues were observed with quality control (qc) results.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.Additional information may be required for diagnosis.¿ siemens is investigating.
Event or Problem Description
The customer reports observation of a false negative patient result when using atellica im hepatitis c (ahcv), lot 464.The customer serves as a regional reference lab, and received a sample which was initially positive for hcv for confirmatory testing.When tested using atellica im ahcv, a nonreactive result was obtained.This result was not reported.Additional testing using an alternate assay method and western blot produced positive results.Further testing was not possible due to insufficient sample volume.The sample was confirmed to be hcv-reactive.The nonreactive atellica im ahcv result was identified as discordant and erroneous.There are no allegations of patient harm or any other adverse consequences in association with the observed result discordance.
Additional Manufacturer Narrative
Mdr 1219913-2024-00368 was initially submitted on 16-jul-2024.Update, 06-sep-2024: siemens has concluded the investigation.A customer from the united states reported observation of a nonreactive (negative) atellica im hepatitis c (ahcv) result which was discordant relative to alternate-method testing.The sample in question produced reproducibly nonreactive atellica im ahcv results.Quality control (qc) results were within expected ranges, and no issues were identified with assay calibration or system-verification testing results.Reagent issues were ruled out as qc was within range and no issues were noted for any other samples.Return of the patient sample for further investigation is not possible, as no sample material remains.Based on the available information, a specific cause for the discordance cannot be determined.The customer is operational, and the reported issue is resolved by routine troubleshooting.There is no evidence of a reagent or instrument problem.Note: in section h6, codes for investigation findings and investigation conclusions have been updated.

• Brand Name: ATELLICA IM HEPATITIS C (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.; registration #1219913; east walpole MA 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 19740828
• Report Number: 1219913-2024-00368
• Device Sequence Number: 14362874
• Product Code: MZO
• UDI-Device Identifier: 00630414597867
• UDI-Public: 00630414597867
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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): 09/09/2024

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: 10/22/2024
• Device Model Number: N/A
• Device Catalogue Number: 10995456
• Device Lot Number: 464
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2024
• Supplement Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown