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	08/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that falsely elevated concentrated carbon dioxide (co2_c) results were obtained on five patient samples on the advia 1800 analyzer.The initial results were not reported to the physician(s).The samples were auto repeated on the original instrument.The auto-repeat results recovered lower than the initial results.The auto-repeat results were reported as the correct results to the physician(s).There is no known reports of patient intervention or adverse health consequences due to the falsely elevated co2_c results.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that falsely elevated concentrated carbon dioxide (co2_c) results were obtained on five patient samples on an advia 1800 analyzer.Quality control (qc) and calibration were within ranges 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 decontaminated the instrument.Siemens requested for the customer to run qc.Further, the cse replaced the water filled main degasser, ran prime 3 and wash 3, performed system check, reviewed reaction curves, cleaned a valve, replaced dilution reaction tray wash up down unit (dwud) nozzle 1, verified probe and mixer alignments, cleaned and rebuilt vertical pumps, cleaned and aligned reaction tray wash up down unit (wud)/dwud nozzles, performed wash 2 and ran calibrations and qc, which recovered within acceptable ranges.Siemens evaluated the event and ruled out reagent issues based on review of qc, which recovered within acceptable ranges.The cause of the falsely elevated co2_c results is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2024-00202 on 06-sep-2024.Additional information (05-sep-2024): siemens further evaluated the event and ruled out reagent issues based on review of quality control (qc), which recovered acceptably.Siemens determined that an instrument malfunction, which was addressed with the service activities mentioned in the initial report, potentially contributed to the falsely elevated concentrated carbon dioxide (co2_c) results.The investigation conclusions code in h6 was updated to reflect the additional information.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 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: emmanuella makridakis ; 511 benedict ave; tarrytown, NY 10591 ; 9086354191
• MDR Report Key: 20157617
• Report Number: 2432235-2024-00202
• Device Sequence Number: 4235373
• 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,Followup
• Report Date (Section B): 09/13/2024

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: 08/13/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 09/13/2024
• 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