MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CHEMISTRY XPT SYSTEM

Model Number	ADVIA CHEMISTRY XPT SYSTEM
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc) to report that falsely depressed calcium_2 (ca_2) results were generated for multiple patient samples on an advia chemistry xpt system.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse checked the oil bath for contamination, and none was found.Next, the cse replaced the reaction tray vessel (rrv) cuvettes and performed a lamp energy check and cell blank, and both were acceptable.Following a check of the reagent probe (rp) positions, the cse repositioned rp1, cleaned the rps, and confirmed their alignment using an alignment gauge.Then, the cse ran a successful precision study, and the customer ran quality controls, which recovered, acceptably.Siemens concluded that cuvettes and alignment issues potentially contributed to the erroneous ca_2 results.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported that falsely depressed calcium_2 (ca_2) results were generated on multiple patient samples on an advia chemistry xpt system.The initial results were reported to the physician(s).The customer indicated that they were rerunning patient samples on an alternate advia chemistry xpt system.The customer also stated that some patients were redrawn for subsequent testing.Results and sample information have not been provided.There are no known reports of patient intervention or adverse health consequences due to the erroneous ca_2 results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2025-00047 on 10-feb-2025.Additional information (25-feb-2025): the customer provided sample identifiers and results for the patients impacted by this event.Sections a1, b5 and b6 were updated to reflect the additional information.
Event or Problem Description
The customer provided calcium_2 (ca_2) results generated on the advia chemistry xpt analyzer for this event.The customer did not specify the date of testing for each sample.Therefore, these results were also included in the supplemental reports for mdr 2432235-2025-00048 and mdr 2432235-2025-00049.Additionally, the customer provided two sample identifiers without any results and did not provide the correct results for most samples.

• Brand Name: ADVIA CHEMISTRY XPT SYSTEM
• Common Device Name: ADVIA CHEMISTRY XPT SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): JEOL LTD; 3-1-2 musashino akishima; registration #: 3003637681; tokyo 196-8 558; JA 196-8558
• Manufacturer Contact: douglas stanton ; 511 benedict avenue; tarrytown, NY 10591 ; 9142706592
• MDR Report Key: 21349573
• Report Number: 2432235-2025-00047
• Device Sequence Number: 8959755
• Product Code: JJE
• UDI-Device Identifier: 00630414595467
• UDI-Public: (01)00630414595467
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K990346
• 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): 03/21/2025

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: ADVIA CHEMISTRY XPT SYSTEM
• Device Catalogue Number: 10723034
• 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: 01/16/2025
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 03/21/2025
• 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