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	06/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that the advia chemistry xpt instrument outputted concentrated carbon dioxide (co2_c) results of >40 mmol/l on multiple patient samples and quality controls.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse inspected the instrument, determined the oil bath was contaminated, cleaned the oil bath, and repaired the reaction tray wash unit (wud) probe line since it was not aspirating.The customer ran calibration, precision check and qc, which recovered acceptably.Siemens further evaluated the event and concluded that the contaminated oil bath, which was addressed with the service activities above, 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
The customer reported that concentrated carbon dioxide (co2_c) results of >40 mmol/l were obtained on all patient samples processed on the advia chemistry xpt instrument on (b)(6) 2024.Then, the customer ran quality controls, and all the quality controls recovered above the upper limit of the assay range (40 mmol/l).The results were not reported to the physician(s).The samples were repeated between three alternate advia chemistry xpt instruments.The repeat results recovered lower and were considered correct.There are no known reports of patient intervention or adverse health consequences due to the falsely elevated co2_c results.

• 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: emmanuella makridakis ; 511 benedict ave.; tarrytown, NY 10591 ; 9086354191
• MDR Report Key: 19798693
• Report Number: 2432235-2024-00156
• Device Sequence Number: 8379869
• Product Code: JJE
• UDI-Device Identifier: 00630414595467
• UDI-Public: (01)00630414595467
• 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): 07/22/2024

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 CHEMISTRY XPT
• Device Catalogue Number: 10723034
• 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: 07/01/2024
• Initial Report FDA Received Date: 07/22/2024
• 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