MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM; ATELLICA IM HEPATITIS C (AHCV) 200T KIT

Catalog Number	10995456
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that they obtained false negative atellica im hepatitis c (ahcv, 482) results on two patient samples vs alternate method.The false negative results were not reported to the physician(s).The samples were repeated on an alternate method, and positive results were obtained, considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the event.
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding false negative atellica im hepatitis c (ahcv) results on two patient samples vs alternate method.Quality control (qc) recovered within the lab ranges.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.¿ siemens is evaluating the event.

• Brand Name: ATELLICA IM
• Common Device Name: ATELLICA IM HEPATITIS C (AHCV) 200T KIT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; registration #: 1219913; 333 coney st.; east walpole MA 02032
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 23973341
• Report Number: 1219913-2026-00005
• Device Sequence Number: 18349058
• Product Code: MZO
• UDI-Device Identifier: 00630414597867
• UDI-Public: (01)00630414597867(10)93794482(17)260814
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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): 05/22/2026

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: 08/14/2026
• Device Catalogue Number: 10995456
• Device Lot Number: 93794482
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2025
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2025
• 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