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	08/21/2024
Type of Reportable Event	Malfunction
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) and calcium_2 (ca_2) results were obtained on multiple patient samples on the advia 1800 analyzer.Quality control (qc) and calibration recovered acceptably on the day of the event.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse performed a full system check, reviewed reaction curves, cleaned a valve, replaced dilution tray wash up down unit (dwud) nozzle 1, verified probe and mixer alignments, cleaned and rebuilt the vertical pumps, cleaned and aligned reaction tray wash up down unit (wud) and dwud nozzles, performed wash 2 and ran calibrations and qc, which recovered within acceptable ranges.Furthermore, the cse decontaminated the instrument, disassembled and cleaned dilution probe valve 1 (dpev1), sample probe valve 1 (spev1), and reagent probe valve 1 (rpev1), verified probe heights and alignments and reviewed reaction curves.Siemens further evaluated the event and ruled out reagent issues based on the review of qc, which showed recovery within acceptable ranges.Siemens concluded the service actions performed by the cse resolved the issue.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 multiple patient samples on the advia 1800 analyzer.The erroneous results were not reported to the physician(s).The samples were repeated on the original instrument.The repeat results recovered lower than the erroneous results and were consistent with the patients¿ clinical histories.The repeat results were considered correct and reported to the physician(s).The customer only provided a subset of falsely elevated co2_c results obtained on patient samples and indicated that erroneous calcium_2 (ca_2) results were also obtained on patient samples.There is no known reports of patient intervention or adverse health consequences due to falsely elevated co2_c and ca_2 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: emmanuella makridakis ; 511 benedict ave.; tarrytown, NY 10591 ; 9086354191
• MDR Report Key: 20183559
• Report Number: 2432235-2024-00203
• Device Sequence Number: 8261491
• 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): 09/10/2024

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: 08/21/2024
• Initial Report FDA Received Date: 09/10/2024
• 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