MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM HEPATITIS C (AHCV); HEPATITIS C VIRUS IMMUNOASSAY

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	04/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed reproducible, non reactive results on one serum patient sample with atellica im hepatitis c (ahcv), lot 440.The results were considered discordant compared to a low positive result on an alternate method.The discordant results were not reported to the physician.There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant atellica im ahcv results.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc) to report reproducible, non reactive results on one serum patient sample with atellica im hepatitis c (ahcv) that were considered discordant compared to a low positive result on an alternate method.The interpretation of results section of the instructions for use (ifu) states: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." the limitations section of the ifu states: "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.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.13,14 additional information may be required for diagnosis." siemens is investigating.
Additional Manufacturer Narrative
Siemens filed initial mdr 1219913-2023-00123 on 2023-05-11.Additional information - 2023-07-12.Siemens concluded investigation for an outside of the united states (ous) customer observation of reproducible, non-reactive results on one serum patient sample with atellica im hepatitis c (ahcv), lot 440.The patient was negative (non-reactive) on two atellica im analyzers but resulted as low positive (reactive) on an alternate test method.There was no medical history or medication list provided, and no date when patient was initially diagnosed.There is no other data suggesting the atellica im ahcv results are aberrant.A review of siemens in-house data for lot 440 shows kit is meeting performance characteristics.Quality control (qc) and calibrations were acceptable and since the sample was repeat non-reactive on two separate atellica im analyzers, it does not appear to be an instrument issue.Based on the available, a product performance issue has not been identified.In section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ATELLICA IM HEPATITIS C (AHCV)
• Common Device Name: HEPATITIS C VIRUS IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney st.; registration #: 1219913; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032
• MDR Report Key: 16916439
• Report Number: 1219913-2023-00123
• Device Sequence Number: 12492911
• 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): 08/09/2023

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: 09/23/2023
• Device Model Number: N/A
• Device Catalogue Number: 10995456
• Device Lot Number: 440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2022
• 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