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	08/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer from outside the united states reports observation of a false negative result for a patient sample when running atellica im hepatitis c (ahcv), lot 440.The sample was repeated on the same analyzer and a similar result was obtained.The same sample was repeated on an alternate method and a higher result was obtained.The alternate method result was agreed with the confirmatory method (riba).The customer service engineer ran svk for both instruments, and both of them passed.They also checked the water station clearance, and it was good during the micro-chemical inspection.They also changed the tip lot number to avoid any variabilities.The interpretation of results section of the atellica im 1600 hcv instructions for use states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." siemens continues to investigate.
Event or Problem Description
The customer reports observation of a false negative result for a patient sample when running atellica im hepatitis c (ahcv), lot 440.The initial result was not reported to the physician(s).The sample was repeated on the same analyzer and a similar result was obtained.The same sample was repeated on an alternate method and a higher result was obtained.The alternate method result was agreed with the confirmatory method (riba).There are no known reports of patient intervention or adverse health consequences due to the discordant, hcv result.
Additional Manufacturer Narrative
Initial mdr 1219913-2023-00186 was filed on 08-sep-2023.Additional information - 30-oct-2023 and 07-nov-2023: an outside the united states (ous) customer reported atellica im false-negative hcv samples as compared to alternate methods siemens has reviewed the findings of hcv testing at this facility.No root cause has been identified.No medical history of the patient was provided.Samples are not available to be tested in-house.Quality control (qc) and calibrations were appropriate.It is possible that the patient has an old infection and titers of the antibodies have fallen below detection or there could be interfering substance.Siemens reviewed internal information to determine if a certain population may be more susceptible to any possible interferent.Additionally, siemens reviewed published literature to understand if antiviral medications could potentially impact immunoassay results.This review did not identify a possible root cause.System had extensive troubleshooting including incubation ring alignment, tip tray alignment, reagent probes and sample probe alignment, luminometer, pmt replaced and all tubing was replaced and system was decontaminated twice.In section h6, the investigation finding 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 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; 333 coney street; east walpole MA 02032
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 17709835
• Report Number: 1219913-2023-00186
• Device Sequence Number: 11299954
• Product Code: MZO
• UDI-Device Identifier: 00630414597867
• UDI-Public: 00630414597867
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: 10995456
• 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): 11/27/2023

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): Follow-Up
• Initial Date Received by Manufacturer: 08/16/2023
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 11/27/2023
• 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