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

Model Number	ADVIA CHEMISTRY 1800
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted a siemens customer care center and reported that falsely elevated concentrated carbon dioxide (co2_c) results were obtained on seven patient samples from an advia chemistry 1800 instrument.Quality control (qc) recovered acceptably for co2_c prior to running the samples.There were no issues with water quality nor with the laboratory temperature.There were no system errors.A siemens customer service engineer (cse) was dispatched to the customer's site.The cse rebuilt all onboard pump seals.Then, the cse replaced the occluded dilution tray wash unit (dwud) skimmer line (for probe 1) and the degasser module.All probe and mixer alignments were verified, and an instrument total service visit (tsv) was performed.Quality control recovered acceptably.Siemens further investigated the incident and determined the instrument's need of routine service 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
Falsely elevated concentrated carbon dioxide (co2_c) results were obtained on seven patient samples from an advia chemistry 1800 instrument.The falsely elevated results were not reported to the physician(s).The samples were either repeated on an alternate instrument or both instruments.The lower repeat results from the alternate instrument were considered correct and reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the falsely elevated co2_c results.

• Brand Name: ADVIA CHEMISTRY 1800
• Common Device Name: ADVIA CHEMISTRY 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: christina lam ; 511 benedict ave; tarrytown, NY 10591 ; 9142550090
• MDR Report Key: 15192545
• Report Number: 2432235-2022-00219
• Device Sequence Number: 12265474
• 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): 08/09/2022

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 CHEMISTRY 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: 07/20/2022
• Initial Report FDA Received Date: 08/09/2022
• 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 Sex: Unknown