MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CHEMISTRY; ADVIA 1800 CHEMISTRY SYSTEM

Model Number	ADVIA 1800
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Three (3) discordant falsely elevated carbon dioxide concentrated (co2_c) patient sample results were obtained on an advia® 1800 clinical chemistry system.The falsely elevated patient results were not reported to the physician.The same samples were reprocessed on the same advia® 1800 clinical chemistry system.The lower reprocessed results were considered correct and reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the falsely elevated carbon dioxide concentrated (co2_c) patient results.
Additional Manufacturer Narrative
A united states customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding three (3) falsely elevated carbon dioxide concentrated (co2_c) patient results obtained on an advia® 1800 clinical chemistry system.Siemens is investigating the event.
Additional Manufacturer Narrative
Additional information (05-jan-2024): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc evaluated the information provided by the customer and the instrument data logs.A siemens customer service engineer (cse) was dispatched to the customer's site.The cse performed maintenance that was part of standard troubleshooting including flushing and cleaning the water bottles, decontaminating the system which returned the system to normal operation.Calibration and quality control recovered within the customer's expected ranges.Repeat of the same samples yielded the expected results.Hsc concluded that the cause of the event was consistent with contaminated water/poor water quality.The customer is operational.The device is performing within specifications.No further evaluation is required.Sections h3 and h6 have been updated to reflect the hsc investigation.Initial mdr 2432235-2023-00289 was filed on 08-nov-2023.

• Brand Name: ADVIA CHEMISTRY
• Common Device Name: ADVIA 1800 CHEMISTRY SYSTEM
• 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: linda barletta ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 18091116
• Report Number: 2432235-2023-00289
• Device Sequence Number: 14983282
• Product Code: JJE
• UDI-Device Identifier: 00630414534794
• UDI-Public: 00630414534794
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 01/24/2024

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
• Device Catalogue Number: SMN 10315183
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2023
• Supplement Date Received by Manufacturer: 01/05/2024
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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