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	08/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that they obtained an erroneously depressed calcium_2 (ca_2) result on a patient sample on an atellica ch 930 analyzer.The initial result was not reported to the physician(s).The sample was repeated on the same analyzer four times.The repeat results obtained were consistent with the patient¿s clinical picture and considered correct.A repeat result of 2.665 was reported to the physician(s) as correct result.There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed ca_2 result.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding an erroneously depressed calcium_2 (ca_2) result obtained on a patient sample on an atellica ch 930 analyzer.Siemens reviewed the instrument data files and the information provided by the customer and found that the quality control (qc) showed slight imprecision and, in some instances, recovered outside of the customer's expected ranges.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit the cse inspected the analyzer and replaced dilution arm and water filter, performed manual and auto alignments, primed system and ran auto check which, passed, ran qc and precision which recovered within acceptable ranges.Based on the available information, siemens concludes that the probable cause of the erroneously depressed ca_2 result was instrument related.The service actions taken were part of normal troubleshooting.The instrument is working according to the specification.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 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 ; +919(870)577433
• MDR Report Key: 50584370
• Report Number: 2432235-2026-00212
• Device Sequence Number: 13335471
• 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): 09/03/2026

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: Not provided
• Initial Report FDA Received Date: 09/03/2026
• 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: 89 YR
• Patient Sex: Female