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	04/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Falsely elevated concentrated carbon dioxide (co2_c) results were obtained on 3 patient samples on an advia chemistry 1800 instrument.The discordant results were not reported to the physician(s).The samples were repeated on an alternate advia chemistry 1800 instrument.The repeat results from an alternate instrument were reported to the physician(s) as the correct results.There are no known reports of patient intervention or adverse health consequences due to the discordant co2_c results.
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 3 patient samples on an advia chemistry 1800 instrument.The customer indicated that there were no issues with quality controls (qc) and calibration at the time of sample processing.A siemens customer service engineer (cse) was dispatched to the customer's site.During this visit, the cse performed a full system check, noted bubbles in the water reservoir and replaced the general electric valve (gev).Then, the cse found the drain line sitting down in waste fluid and trimmed the tubing so that it was above the fluid level in the waste tank.The cse observed a clog in the ion selective electrode (ise) drain tubing, cleared clog, and verified probe alignments.Then, the cse noted that the overflow line on dilution tray wash unit (dwud) nozzle 2 was completely clogged, and the reaction tray wash unit (wud) nozzle was partially clogged.The cse removed the lines, cleared out the clogs, cleaned the vacuum nozzle lines on both dwud and wud, replaced the nozzle set and adjusted the height on the dwud nozzle 8.The cse observed diminished vacuum and replaced the vacuum compressor seals and reed seals.Then, the cse increased vacuum pressure, performed full system bleach decontamination, and ran quality controls which recovered acceptably.The cause of the falsely elevated co2_c results is unknown.The instrument is performing according to specifications.No further evaluation of these devices is required.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2022-00144 on 11-may-2022.Additional information on (11-may-2022): in a subsequent service visit, the cse replaced the dilution probe valve 1 (dpev1) and instructed the customer to run quality control (qc) and monitor the instrument.The customer also performed monthly maintenance on the instrument and continued to monitor the instrument.The cse contacted the customer to follow up on the issue.The customer confirmed that the assay performance improved after the dpev1 replacement.Siemens further investigated the issue and concluded that the potential cause of the falsely elevated concentrated carbon dioxide (co2_c) results is due to an instrument in need of routine service.The instrument is performing according to specifications.No further evaluation of this device is required.

• 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 avenue; tarrytown, NY 10591 ; 9142550090
• MDR Report Key: 14362156
• Report Number: 2432235-2022-00144
• Device Sequence Number: 4958861
• 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): Unknown
• 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): 06/02/2022

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: 04/27/2022
• Supplement Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 06/02/2022
• 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