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	11/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported falsely elevated concentrated carbon dioxide (co2_c) results were obtained on three patient samples on an advia 1800 analyzer.Calibration was acceptable and quality control (qc) recovered high on level 2 on the day of event.The customer reran qc, which recovered within acceptable range on both levels.A siemens customer service engineer (cse) was dispatched to the customer's site.During the visit, the cse inspected the instrument, checked all valves on reaction tray wash unit (wud) and dilution reaction tray wash unit (dwud), which were functioning normally, verified water pressure, no leaks were observed, reflanged cuvette wash, rinsed input lines, ran wash 3, observed obstruction in the cuvette conditioner, re-adjusted the cuvette conditioner, performed full system check, observed contamination in water lines, performed full system decontamination, ran qc, which recovered acceptably.Siemens evaluated the event and determined that the contamination in waterlines potentially contributed to the falsely elevated co2_c results.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported that falsely elevated concentrated carbon dioxide (co2_c) results were obtained on three patient samples on an advia 1800 analyzer.The initial results were not reported to the physician(s).The sample identified as (b)(6) was reprocessed on the original analyzer, however, the samples identified as (b)(6) were reprocessed on an alternate advia 1800 analyzer.The repeat results recovered lower than the initial results and were in line with lab expectations.The repeat results were considered correct, and the repeat results were 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.

• 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: 20804234
• Report Number: 2432235-2024-00321
• Device Sequence Number: 9392477
• 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): 11/28/2024

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: 11/08/2024
• Initial Report FDA Received Date: 11/28/2024
• 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