MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC ADVIA 1800

Model Number	ADVIA 1800
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A falsely depressed concentrated carbon dioxide (co2_c) result was obtained on a patient sample on an advia 1800 instrument.The falsely depressed result was not reported to the physician(s).The sample was repeated on an alternate advia 1800 instrument.The repeat result was higher than the discordant result.The repeat result was reported, as the correct result, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely depressed co2_c result.
Additional Manufacturer Narrative
A united states customer contacted a siemens customer care center (ccc) and reported a falsely depressed concentrated carbon dioxide_2 (co_2c) result was obtained on a patient sample on an advia 1800 instrument.Quality controls recovered within acceptable ranges on the day of the event.A siemens customer service engineer (cse) was dispatched to the customer's site.The cse performed a total service visit (tsv).The dilution probe pipette (dpp) assembly and alignments to the aptio track and instrument areas were checked.All probe alignments were found to be acceptable.The reaction tray wash unit (wud) and dilution tray wash unit (dwud) assemblies were found to be operating normally.The mixer alignments, water supply pressure, vacuum, lamp voltage and operation were verified.Quality controls (qc) were processed and recovered acceptably.The cause of the event is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA 1800
• Common Device Name: ADVIA 1800
• 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: kristin kehyaian ; 511 benedict ave; tarrytown, NY 10591 ; 9148267101
• MDR Report Key: 15853884
• Report Number: 2432235-2022-00304
• Device Sequence Number: 20445511
• Product Code: JJE
• UDI-Device Identifier: 00630414534794
• UDI-Public: 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): 11/23/2022

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: 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: 11/01/2022
• Initial Report FDA Received Date: 11/23/2022
• 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: 42 YR
• Patient Sex: Female