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

Model Number	ATELLICA CH 930 ANALYZER
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc) and reported that falsely depressed creatinine_2 (crea_2) and creatine kinase (ck_l) results were obtained on a patient sample, and a falsely elevated carbon dioxide, concentrated (co2_c) result was obtained on another patient sample on an atellica ch 930 analyzer.Quality control (qc) was within range prior to running samples on day of the event for the affected assays.Siemens reviewed the instrument data and observed intermittent qc outliers.Siemens reviewed the photometer data and noted that the last two photometer readings were lower than the original reaction curve, indicating contamination or dilution of the reaction cuvette due to a leaking reaction washer probe.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse observed issues with the reaction washer caused by a water dispense valve, ran qc five times, performed a total service, and checked the reagent server 1 sensor.Next, the cse checked and realigned the mixers, as well as the dilution and reaction wash stations.Further, the cse replaced the reagent and dilution mixers, dispense valve, and the integer.Then, the cse ran service method tests (psn10, dmix, smix, and rmix), performed realignment, and ran service method tests (psn10 and dmix) again, auto check, and qc, all of which passed.Siemens evaluated the event and determined that a reaction cuvette washer issue potentially contributed to the erroneous crea_2, ck_l, and co2_c results.The analyzer is performing within specifications.No further evaluation is required.
Event or Problem Description
The customer reported that falsely depressed creatinine_2 (crea_2) and creatine kinase (ck_l) results were obtained on a patient sample, and a falsely elevated carbon dioxide, concentrated (co2_c) result was obtained on another patient sample on an atellica ch 930 analyzer.The erroneous results were not reported to the physician(s).The samples were repeated on an alternate atellica ch 930 analyzer.The repeat results matched the patient¿s clinical picture.The repeat results were determined to be correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneous crea_2, ck_l, and co2_c results.

• 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.; 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: 24786638
• Report Number: 2432235-2026-00088
• Device Sequence Number: 14985847
• Product Code: JJE
• UDI-Device Identifier: 00630414002163
• UDI-Public: (01)00630414002163
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 04/05/2026

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: 03/12/2026
• Initial Report FDA Received Date: 04/05/2026
• 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 Sex: Unknown