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	05/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a falsely elevated concentrated carbon dioxide (co2_c) result was obtained on a patient sample on an advia chemistry 1800 instrument.The initial result was reported to the physician(s), who questioned the result.The sample was repeated on the original instrument.The repeat result recovered lower than the initial result and was consistent with the patient's clinical history.The repeat result was considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely elevated co2_c result.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that an advia chemistry 1800 instrument outputted a falsely elevated concentrated carbon dioxide (co2_c) result on a patient sample and out-of-range quality control (qc).Qc and calibration were valid before the sample was run.The customer replaced the reagent probe, performed a shutdown wash, and performed qc.A siemens customer service engineer (cse) was dispatched to the customer's site.During this visit, the cse reseated and secured the reagent probe, checked reagent tray positions to probe alignment, and ran qc, which recovered acceptably.Siemens further evaluated the event and concluded that the malfunctioned probe potentially contributed to the falsely elevated co2_c result.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 ave.; tarrytown, NY 10591 ; 9142550090
• MDR Report Key: 19505587
• Report Number: 2432235-2024-00131
• Device Sequence Number: 15181798
• Product Code: JJE
• UDI-Device Identifier: 00630414534794
• UDI-Public: 00630414534794
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 06/10/2024

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 1800
• Device Catalogue Number: 10315183
• 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: 05/19/2024
• Initial Report FDA Received Date: 06/10/2024
• 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