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

Model Number	ADVIA 1800 CHEMISTRY SYSTEM
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that erroneously elevated concentrated carbon dioxide (co2_c) results were obtained on three (3) patient samples on an advia® 1800 clinical chemistry system.Quality control (qc) and calibration were within range on the day of the event.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse inspected the instrument, performed a total service call and instrument decontamination.The customer ran qc.Further, the cse replaced water filled main degasser, ran prime 3 and wash 3, performed system check, reviewed reaction curves, cleaned gev valve, swapped dilution reaction tray wash up down unit (dwud) nozzle 1, verified probe and mixer alignments, cleaned/rebuilt vertical pumps, cleaned/aligned reaction tray wash up down unit (wud)/dwud nozzles, performed wash 2 and ran calibrations and qc.Siemens evaluated the event and ruled out reagent issues based on review of qc which showed recovery within acceptable ranges.The cause of the falsely elevated co2_c results is unknown.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
The customer reported to siemens that they obtained erroneously elevated carbon dioxide concentrated (co2_c) results on three (3) patient samples on an advia® 1800 clinical chemistry system.The erroneous patient results were not reported to the physician.The same samples were auto reprocessed on the same advia® 1800 clinical chemistry system and the results recovered within the normal range.The same samples were reprocessed on an alternate advia® 1800 clinical chemistry system and the results recovered within the normal range.The reprocessed results were reported to the physician as the correct results.The customer declined to provide the information about correct reported results.There is no known reports of patient intervention or adverse health consequences due to the erroneously elevated carbon dioxide concentrated (co2_c) results.

• 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 ; 511 benedict ave.; tarrytown, NY 10591
• MDR Report Key: 20144978
• Report Number: 2432235-2024-00201
• Device Sequence Number: 18207632
• 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): 09/05/2024

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 CHEMISTRY SYSTEM
• Device Catalogue Number: SMN 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: 08/15/2024
• Initial Report FDA Received Date: 09/05/2024
• 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 Sex: Unknown