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

Model Number	ADVIA CHEMISTRY XPT
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states customer contacted a siemens customer care center (ccc) and reported a falsely elevated concentrated carbon dioxide (co2_c) result that was obtained on a patient sample on an advia chemistry xpt instrument.The quality control (qc) and calibration were acceptable on the day of the event.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse evaluated the aspiration performance of the wash up/down assembly (wud) nozzles and did not find a blockage.Then, the cse started a system shutdown wash and observed that the cuvettes started to overflow when aspirating on vacuum trap 1 (vtr1).The cse also observed a blockage in the elbow fitting of the vacuum out electronic valve 1 (voev1), which was restricting the vacuum and causing the cuvette overflow.Then, the cse drained the contaminated bath oil from the instrument and cleaned the build-up from around the reaction bath.The cse fitted a new rotary reaction vessel (rrv) oil filter and primed the instrument with fresh reaction bath oil.The cse also checked lamp energy and performed cell blank.Lastly, the cse ran qc, which recovered acceptably.The cause of the falsely elevated co2_c result is unknown.The instrument is performing according to specifications.No further evaluation of these devices is required.
Event or Problem Description
A falsely elevated concentrated carbon dioxide (co2_c) result was obtained on a patient sample on an advia chemistry xpt instrument.The erroneous result was not reported to the physician(s).The sample was repeated on the same instrument.The repeat result recovered lower than the erroneous result and was considered correct.There are no known reports of patient interventions or adverse health consequences due to the falsely elevated co2_c result.

• Brand Name: ADVIA CHEMISTRY XPT
• Common Device Name: ADVIA CHEMISTRY XPT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; 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: 17291055
• Report Number: 2432235-2023-00214
• Device Sequence Number: 12353810
• Product Code: JJE
• UDI-Device Identifier: 00630414595467
• UDI-Public: 00630414595467
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2023

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 XPT
• Device Catalogue Number: 10723034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 07/10/2023
• 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