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	07/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Nonreactive (negative) hepatitis c (ahcv) results were obtained on a patient sample on an atellica im 1600 analyzer which were considered discordant with the reactive (positive) results from an alternate method.The discordant nonreactive (negative) results were not reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant nonreactive ahcv results.
Additional Manufacturer Narrative
An outside united states (ous) customer contacted a siemens customer care center to report nonreactive (negative) hepatitis c (ahcv) results were obtained on a patient sample on an atellica im 1600 analyzer which were considered discordant with the reactive (positive) results from an alternate method.The discordant nonreactive (negative) results were not reported to the physician(s).No issues with quality control (qc).The instructions for use (ifu) states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." the ifu states in the limitations section: "assay performance characteristics have not been established for the atellica im ahcv assay used in conjunction with other manufacturers' assays for specific hcv serological markers.Laboratories are responsible for establishing their own performance characteristics.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." siemens healthcare diagnostics is investigating.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2023-00161 on august 11, 2023.An outside united states (ous) customer contacted a siemens customer care center to report nonreactive (negative) hepatitis c (ahcv) results were obtained on a patient sample on an atellica im 1600 analyzer which were considered discordant with the reactive (positive) results from an alternate method.The discordant nonreactive (negative) results were not reported to the physician(s).October 10, 2023 additional information: the initial issue was reported as atellica im ahcv false negative results on lot 444.The following actions have been performed: -siemens evaluated patient data along with medications.No known interference with drugs listed.-the quality control (qc) data was reviewed and reported acceptable.Siemens made multiple attempts requesting additional information and sample availability to investigate for potential cause but no response was received from the customer.No further evaluation of the device is required.The investigation findings and investigation conclusion codes were 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 street; e. walpole MA 02032
• Manufacturer Contact: eiman sulieman ; 333 coney st.; east walpole, MA 02032 ; 7372808688
• MDR Report Key: 17511930
• Report Number: 1219913-2023-00161
• Device Sequence Number: 17537081
• Product Code: MZO
• UDI-Device Identifier: 00630414597867
• UDI-Public: 00630414597867
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P030056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 10/12/2023

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: 01/29/2024
• Device Model Number: N/A
• Device Catalogue Number: 10995456
• Device Lot Number: 444
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2023
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 10/12/2023
• 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