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

Model Number	ATELLICA CH 930 ANALYZER
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported an inaccuracy with two gentamicin results obtained for one patient on the atellica ch 930 analyzer with serial number (b)(6).One result changed and required correction in the laboratory information system.The customer performed troubleshooting, which included replacement of the dilution probe, and photometer lamp.The customer did not report any other issues or test results affected by the quality control (qc) being out of range.Siemens is investigating the event.
Event or Problem Description
The customer reported an inaccuracy with two gentamicin (gent) results obtained for one patient on the atellica ch 930 analyzer with serial number (b)(6).The initial result of 0.64 mg/l was reported to the physicians.After observing that quality control (qc) was out of range and replacing the dilution probe, repeat testing was performed on the same analyzer, yielding a result of 1.85 mg/l.The same patient sample was then tested on an alternate atellica ch 930 analyzer with acceptable quality control, and the result of 1.0 mg/l was considered correct.A corrected report was issued and communicated to the physicians.There are no known reports of patient intervention or adverse health consequences associated with this event.
Additional Manufacturer Narrative
The initial medical device report (mdr) 2432235-2026-00096 was filed on 20-apr-2026.Additional information (28-apr-2026): siemens reviewed analyzer data and noted that photometer readings showed a bias in absorbance when comparing the two initial replicates.Absorbance trending was uniform during assay processing, and no process errors were identified at the time of processing patient sample id hm2628dlx.Siemens was informed that the customer performed gentamicin troubleshooting and testing, which included running additional replicates of the same control material.Siemens dispatched a customer service engineer to the customer site.The customer service engineer performed routine hardware troubleshooting, including assay calibration and replacement of the dilution probe.The operator informed siemens that a system error, ¿photometer lamp intensity,¿ was observed, prompting routine photometer troubleshooting.The source lamp was replaced, and alignment protocols were completed.The customer subsequently monitored gent assay performance and reported no further instances of inaccuracy, with quality control recovery remaining within the customer¿s allowable range.Siemens concluded that the gent result inaccuracy and out-of-range quality control recovery were related to a mechanical failure and that service intervention at the source lamp resolved the issue.The customer is operational, the analyzer is functioning as specified, and no further evaluation is required.Siemens updated section h6 to include new codes that reflect the investigation conclusion.

• 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: 24926755
• Report Number: 2432235-2026-00096
• Device Sequence Number: 20178658
• Product Code: JJE
• UDI-Device Identifier: 00630414002163
• UDI-Public: (01)00630414002163
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 05/19/2026

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: 03/25/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2019
• 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