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

Model Number	ADVIA CHEMISTRY XPT
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care.Quality controls (qcs) recovered within ranges on the day of the event.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During this visit, the cse checked the aspiration on the dilution tray wash unit (dwud) and the reaction tray wash unit (wud), probe and mixer alignments, vertical pumps, and the lamp energy.A precision run was performed, and the results were acceptable.Qcs were also performed, which recovered within ranges.The cause of the erroneous co2_c and ecre_2 results is unknown.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 2 patient samples on an advia chemistry xpt instrument.Additionally, a falsely depressed enzymatic creatinine_2 (ecre_2) result was obtained on another patient sample on the same instrument.The co2_c result for the sample identified as (b)(4) was reported to the medical staff, but the result was not seen by physician(s).The co2_c result for the sample identified as (b)(4) and the ecre_2 result for the sample identified as (b)(4) were not reported to the physician(s).The samples were repeated on an alternate advia chemistry xpt instrument.The repeat results were reported, as the correct results, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneous co2_c and ecre_2 results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2024-00014 on 23-jan-2024.Additional information (24-jan-2024): siemens further evaluated the event and concluded that general cleanliness and maintenance issues contributed to the erroneous concentrated carbon dioxide (co2_c) and enzymatic creatinine_2 (ecre_2) results.The issue was resolved after performing a system shutdown wash.The investigation conclusions code in section h6 was updated to reflect the additional information.The analyzer is performing within specifications.No further evaluation of this analyzer is required.

• Brand Name: ADVIA CHEMISTRY XPT
• Common Device Name: ADVIA CHEMISTRY XPT
• 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: kristin kehyaian ; 511 benedict ave; tarrytown, NY 10591 ; 9148267101
• MDR Report Key: 18566757
• Report Number: 2432235-2024-00014
• Device Sequence Number: 17807479
• 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,Followup
• Report Date (Section B): 02/06/2024

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): Follow-Up
• Initial Date Received by Manufacturer: 01/14/2024
• Supplement Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 02/06/2024
• 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