MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 1800 CHEMISTRY SYSTEM; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number	ADVIA 1800 CHEMISTRY SYSTEM
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	12/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted siemens to report that a 4274 ise calibration slope error was generated from the ion selective electrode (ise) module on an advia 1800 chemistry system.A siemens customer service engineer (cse) was dispatched to the customer site to inspect the ise module.The cse found salt deposits around the ise module.The cse cleaned the ise module, checked the ise mixer and the ise electrodes.The cse ran calibration and quality control (qc) materials with acceptable results.The cause of the 4274 ise calibration slope error is unknown.The system is performing within specifications.No further evaluation of this system is needed.
Event or Problem Description
The customer contacted siemens to report that a 4274 ise calibration slope error was generated from the ion selective electrode (ise) module on an advia 1800 chemistry system.The error is posted in the alarm log and the error informs the operator to repeat the ise calibration.Sodium, potassium and chloride patient sample test results were flagged with an asterisk (*) indicating a calibration error.The initial test results were not released to a physician.There are no reports of injury or a delay in reporting test results due to the event.

• Brand Name: ADVIA 1800 CHEMISTRY SYSTEM
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave.; tarrytown NY 10591
• Manufacturer (Section G): JEOL LTD; 3-1-2 musashino akishima; tokyo 00019 6855; JA 0001968558
• Manufacturer Contact: karl aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9142550572
• MDR Report Key: 21118491
• Report Number: 2432235-2025-00015
• Device Sequence Number: 7436942
• Product Code: JJE
• UDI-Device Identifier: 00630414534794
• UDI-Public: (01)00630414534794
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/09/2025

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 1800 CHEMISTRY SYSTEM
• Device Catalogue Number: 10315183
• 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: 12/18/2024
• Initial Report FDA Received Date: 01/09/2025
• Date Device Manufactured: 03/03/2016
• 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