MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM 1600 ANALYZER

Model Number	ATELLICA IM 1600 ANALYZER
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens customer care center (ccc) and reported that an erroneous non-reactive (negative) atellica im antibodies to hepatitis c virus (ahcv) result was obtained on a patient sample on an atellica im 1600 analyzer.A siemens customer service engineer (cse) was dispatched to the customer's site.During the visit, the cse performed the service activities on the analyzer.Siemens is evaluating the event.
Event or Problem Description
The customer reported that an erroneous non-reactive (negative) atellica im antibodies to hepatitis c virus (ahcv) result was obtained on a patient sample on an atellica im 1600 analyzer.The erroneous result was reported to the physician(s), who questioned the result.For troubleshooting purposes, the sample was retested on an alternate atellica im 1600 analyzer and obtained a non-reactive result.The sample was repeated on an alternate test method and obtained a reactive result which was considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to this event.
Additional Manufacturer Narrative
Siemens filed initial mdr 2432235-2025-00191 on 17-jul-2025.Additional information (28-jul-2025): siemens reviewed the instrument data and determined that quality control (qc) and calibration were recovered acceptably on the day of the event.The customer replaced the instrument; therefore, siemens recommended service activities were not performed on the original analyzer.Based on the information provided and a review of the available instrument data, the cause of the false negative hcv result is unknown.No further evaluation is required.The investigation findings and investigation conclusions code in section h6 were updated to reflect the additional information.

• Brand Name: ATELLICA IM 1600 ANALYZER
• Common Device Name: ATELLICA IM 1600 ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; registration #: 2247117; flanders NJ 07836
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 22529003
• Report Number: 2432235-2025-00191
• Device Sequence Number: 17994630
• Product Code: JJE
• UDI-Device Identifier: 00630414002026
• UDI-Public: (01)00630414002026
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K151792
• 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): 08/22/2025

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 Model Number: ATELLICA IM 1600 ANALYZER
• Device Catalogue Number: 11066000
• 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: 06/23/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown