MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 1800 ANALYZER

Model Number	ADVIA 1800 ANALYZER
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that a falsely depressed concentrated carbon dioxide (co2_c) result was obtained on a patient sample on an advia 1800 analyzer.Quality control (qc) was within range on the day of the event.The customer performed routine maintenance, inspected the instrument for leaks, and confirmed that there was no leak and no compromised tubing's.A siemens customer service engineer (cse) was dispatched to the customer's site.During the visit, the cse inspected the instrument, adjusted misaligned reagent probes to wash stations, verified dispense functionality of all probes, reaction tray wash unit (wud) and dilution reaction tray wash unit (dwud), aspirate functionality of wud and dwud and lamp energy on all wavelengths, and observed no issues.The customer ran qc, which recovered acceptably.Siemens reviewed the instrument data and ruled out reagent issues based on a review of qc which showed recovery within acceptable ranges and ruled out instrument performance issues based on calibration, which was acceptable.Siemens further evaluated the event and determined that the sample handling issue potentially contributed to the falsely depressed co2_c result.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported that a falsely depressed concentrated carbon dioxide (co2_c) result was obtained on a patient sample on an advia 1800 analyzer.The initial result was not reported to the physician(s).The sample was reprocessed on the original analyzer.The repeat result recovered higher than the initial result.The repeat result was reported as a correct result to the physician(s).There are no known reports of patient intervention or adverse health consequences due to a falsely depressed co2_c result.

• Brand Name: ADVIA 1800 ANALYZER
• Common Device Name: ADVIA 1800 ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave.; tarrytown NY 10591
• Manufacturer (Section G): JEOL LTD; 3-1-2 musashino akishima; registration #: 3003637681; tokyo 196-8 558; JA 196-8558
• Manufacturer Contact: mekala g ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 840457474
• MDR Report Key: 20630064
• Report Number: 2432235-2024-00286
• Device Sequence Number: 7411000
• Product Code: JJE
• UDI-Device Identifier: 00630414534794
• UDI-Public: (01)00630414534794
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/07/2024

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 ANALYZER
• 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: 10/17/2024
• Initial Report FDA Received Date: 11/07/2024
• 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: 83 YR
• Patient Sex: Female