MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 1800 CHEMISTRY SYSTEM

Model Number	ADVIA 1800 CHEMISTRY SYSTEM
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
One falsely depressed creatinine (enzymatic, ecre_2) test result was obtained on one patient sample from an advia 1800 chemistry system.The initial discordant result was reported to the physician(s).The sample was repeated on the same advia 1800 and a higher test result was obtained.The repeat test result was reported as the correct result to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely depressed ecre_2 test result.
Additional Manufacturer Narrative
An outside the unites states customer contacted siemens to report that one falsely depressed creatinine (enzymatic, ecre_2) test result was obtained on one patient sample from an advia 1800 chemistry system.A siemens customer service engineer (cse) was dispatched to the customer site to inspect the system.The cse reviewed the available data, including the reaction monitor, and found that the spectrophometer lamp was producing unusual readings.The cse replaced the lamp, ran a lamp energy check, then the cell blank and repeated several patient samples with acceptable results.Siemens is investigating.
Additional Manufacturer Narrative
The initial mdr was filed on 02-nov-2022.Additional information (09-nov-2022): siemens reviewed the available information and concludes that system verification testing was completed with acceptable results after the spectrophometer lamp was replaced.The cause of the falsely depressed creatinine (enzymatic, ecre_2) test result was the spectrophometer lamp.The analyzer is performing within specifications.No further evaluation of this analyzer is needed.

• Brand Name: ADVIA 1800 CHEMISTRY SYSTEM
• Common Device Name: ADVIA 1800
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): JEOL LTD; registration #: 3003637681; 3-1-2 musashino akishima; tokyo, 196-8 558; JA 196-8558
• Manufacturer Contact: karl aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9142550572
• MDR Report Key: 15713845
• Report Number: 2432235-2022-00294
• Device Sequence Number: 11992894
• Product Code: JJE
• UDI-Device Identifier: 00630414534794
• UDI-Public: 00630414534794
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2022

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 1800 CHEMISTRY SYSTEM
• 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: 10/27/2022
• Supplement Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 11/02/2022
• Supplement Report FDA Received Date: 11/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2013
• 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 Age: 75 YR
• Patient Sex: Male