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

Model Number	ATELLICA CH 930 ANALYZER
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that quality control (qc) results were inconsistent for multiple assays and that a falsely elevated inorganic phosphorus (ip) result for one patient sample was obtained on the atellica ch 930 analyzer and reported to physicians.Siemens assisted the customer in checking the wash station and confirmed there were no signs of dripping around the needles.The autocheck, autocheck reaction washer, and autocheck dilution washer were verified with no issues.The customer confirmed that cuvettes were not filled to the top and that there was no bottle inversion in consumables.Siemens dispatched a customer service engineer (cse).Services performed included an autocheck automatic verification test and inspections of the reaction washer probe r3 and the reaction and dilution wash stations.The customer service engineer replaced the tubing, probe, and valve r3, and verified there were no leaks at the analyzer¿s water supply manifold.The dilution mixer was noisy; therefore, the assembly was replaced and realigned.The lamp, probes (dilution and sample), and mixers (reagent and sample) were replaced and aligned.Quality control (qc) testing confirmed that results were out of range; therefore, additional services were performed.These included replacing solution #4, reaction and dilution cuvette rings, inspecting the reagent arm (r2), and replacing the valve, pressure sensor, and r2 probe.The cse also checked the alignment of the lamp and photometer, drained and refilled the bath, ran the autocheck, and inspected the analyzer fluidics for bubbles or air intake in the water supply circuit for the wash probes and arms.The valves managing the water supply to the reaction washer station were proactively replaced, and siemens continues to investigate the event.
Event or Problem Description
The customer reported that a falsely elevated inorganic phosphorus (ip) result for one patient sample was obtained on the atellica ch 930 analyzer and reported to physicians.The customer used the same sample to perform repeat testing on an alternate atellica ch 930 analyzer, with quality control (qc) results that were acceptable, and noted that the repeat result was correct.The customer issued a corrected report.There are no known reports of patient intervention or adverse health consequences due to the event.
Additional Manufacturer Narrative
The initial medical device report (mdr) 2432235-2026-00079 was filed on march 20, 2026.Additional information (april 7, 2026): siemens reviewed the autocheck and the services performed and noted that the customer service engineer (cse) identified an air leak in the water manifold.The customer service engineer replaced the water manifold assembly, verified the performance of the atellica ch 930 analyzer, and confirmed that quality control (qc) results were within specification.The cause of the event was determined to be the water manifold assembly.The customer is operational, the analyzer is functioning as specified, and no further evaluation is required.

• Brand Name: ATELLICA CH 930 ANALYZER
• Common Device Name: ATELLICA CH 930 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: rolando hualpa ; 511 benedict ave.; tarrytown, NY 10591 ; 9143485874
• MDR Report Key: 24649048
• Report Number: 2432235-2026-00079
• Device Sequence Number: 15954633
• Product Code: JJE
• UDI-Device Identifier: 00630414002163
• UDI-Public: (01)00630414002163
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 05/01/2026

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: 03/09/2026
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2020
• 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