MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH 930 ANALYZER

Model Number	ATELLICA CH 930 ANALYZER
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that they obtained erroneously depressed microalbumin_2 (alb_2) result on a patient sample on an atellica ch 930 analyzer.The erroneous result was reported to the physician(s).The sample was repeated on an alternate atellica ch 930 analyzer.The repeat result recovered lower than the initial result, considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed alb_2 result.
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding erroneously depressed microalbumin_2 (alb_2) result on a patient sample on an atellica ch 930 analyzer.Quality control (qc) recovered acceptably before the event and when qc ran after the event, the analyzer presented an error in the analyzer subsystem, canceling a large part of the tests.After this signal, the qc recovered outside the acceptable range.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse inspected the analyzer and found that the reagent mixer impeller was loose, impeller was correctly replaced in its housing.Then, the cse performed the self-check and found that the probe 4 of the washing station was leaking and the solenoid valve was replaced.Further, the cse ran self-check which passed.Siemens is evaluating the event.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2026-00081 on 27-mar-2026.Additional information (30-apr-2026): siemens has concluded the investigation of the event.Based on the available information, the cause of the erroneously depressed result cannot be determined as multiple part replacements and absence of logger files.The customer is operational.A product problem was not identified.The instrument is performing according to specifications.No further evaluation is required.Note: in section h6, the codes for investigation findings and investigation conclusions have been updated to reflect the additional information.

• Brand Name: ATELLICA CH 930 ANALYZER
• Common Device Name: ATELLICA CH 930 ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown; NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; registration #: 2247117; 62 flanders bartley rd; 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: 24711187
• Report Number: 2432235-2026-00081
• Device Sequence Number: 17664288
• Product Code: JJE
• UDI-Device Identifier: 00630414002163
• UDI-Public: (01)00630414002163
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K151767
• 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 Model Number: ATELLICA CH 930 ANALYZER
• Device Catalogue Number: 11067000
• 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: 03/02/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/22/2026
• 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 Age: 84 YR
• Patient Sex: Male