MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM; ATELLICA IM BR 27.29 (BR)

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer reported observation of an elevated atellica im br 27.29 (br) result which was discordant relative to repeat testing.Siemens is evaluating the event.
Event or Problem Description
The customer reported observation of an elevated atellica im br 27.29 (br) result which was discordant relative to repeat testing when using lot# 275.An initial elevated br result was obtained for a patient sample in question.The elevated result was reported to the physician(s), who questioned the result.The same sample was retested at an alternate facility, yielding a normal result; however, the specific value was not provided.The sample was then repeated on the original analyzer and produced a significantly lower (normal) result.A newly collected sample was also tested and generated a result consistent with the lower result, which matched the patient history and was reported.There are no known reports of patient intervention or adverse health consequences due to this issue.
Additional Manufacturer Narrative
Mdr 1219913-2026-00053 was initially filed on 09-mar-2026.Additional information 25-mar-2026: siemens has concluded the investigation for the issue reported by a united states (us) customer regarding observation of an elevated atellica im br 27.29 (br) result which was discordant relative to repeat testing.Siemens reviewed the instrument data and information provided by the customer.Quality control (qc) results were within the laboratory¿s acceptable limits on the date of the event, and no issues were observed in other patient samples.A siemens customer service engineer (cse) visited the customer site, inspected the instrument, and performed service actions including replacement of the vacuum pressure regulator, primary vacuum tubing, pump blower tubing kit, reservoir cap, and secondary vacuum tubing.The assay was subsequently recalibrated, and post-service actions, testing of qc and patient sample replicates yielded expected results.Based on the available information, the cause of the elevated result could not be determined, as the replacement and servicing of multiple components were performed as part of standard service actions.A product problem was not identified.The customer is operational, and the reported issue was resolved by troubleshooting.Note: in section h6, the codes for investigation findings and investigation conclusions have been updated.

• Brand Name: ATELLICA IM
• Common Device Name: ATELLICA IM BR 27.29 (BR)
• 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: 24543664
• Report Number: 1219913-2026-00053
• Device Sequence Number: 9271968
• Product Code: MOI
• UDI-Device Identifier: 00630414598055
• UDI-Public: (01)00630414598055(10)87224275(17)260926
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: K982680
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2026

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: 09/26/2026
• Device Model Number: N/A
• Device Catalogue Number: 10995478
• Device Lot Number: 87224275
• 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: 02/12/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2025
• 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