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

Model Number	ADVIA 1800 ANALYZER
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that falsely elevated concentrated carbon dioxide (co2_c) results were obtained on eighteen patient samples on an advia 1800 analyzer.The initial results were not reported to the physician(s).The samples identified as (b)(6) were repeated on an alternate advia 1800 analyzer, and the other samples were repeated on an alternate atellica ch (b)(6) analyzer.The repeat results recovered lower than the erroneous results and fit the patients' clinical histories.The repeat results were considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely elevated co2_c results.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc) and reported that falsely elevated concentrated carbon dioxide (co2_c) results were obtained on multiple patient samples on an advia 1800 analyzer.Quality control (qc) was valid at the time of sample processing.A siemens customer service engineer (cse) was dispatched to the customer's site.During the visit, the cse inspected the instrument, ran dispensing and aspiration checks of the reaction tray wash up down unit (wud) and dilution tray wash up down unit (dwud), determined that wud probe 5 was dispensing with high pressure, which caused an overflow on the cuvettes, and found that the water pressure valve was loose.The cse lowered the pressure to the correct value, tightened the adjustment nut/valve, and repaired the wud probe line.The customer ran calibration and precision checks with qc, which recovered acceptably.Siemens reviewed the instrument data and ruled out reagent issues as qc recovered within acceptable ranges on the day of the event.Siemens further evaluated the event and concluded that high dispense pressure from the wud probe 5, addressed with the service actions above, contributed to the falsely elevated co2_c results.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA 1800 ANALYZER
• Common Device Name: ADVIA 1800 ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): JEOL LTD; 3-1-2 musashino akishima; registration #: 3003637681; tokyo 196-8 558; JA 196-8558
• Manufacturer Contact: emmanuella makridakis ; 511 benedict ave.; tarrytown, NY 10591 ; 9086354191
• MDR Report Key: 20013099
• Report Number: 2432235-2024-00188
• Device Sequence Number: 20644930
• Product Code: JJE
• UDI-Device Identifier: 00630414534794
• UDI-Public: (01)00630414534794
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2024

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: 07/29/2024
• Initial Report FDA Received Date: 08/21/2024
• 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