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

Model Number	ADVIA 1800 ANALYZER
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	10/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Three falsely depressed creatinine results and one falsely depressed carbon dioxide result were obtained on four patient sample using an advia 1800 analyzer.The initial results were reported to the physician(s).The same samples for sample ids (b)(6), (b)(6), and (b)(6), were repeated on an alternate advia 1800.The same sample for sample id (b)(6) was repeated on the same instrument.The repeat results were reported, as the correct result, to the physician(s).There were no known reports of patient intervention or adverse health consequence due to this event.
Additional Manufacturer Narrative
An outside of united states (ous) customer reported that three falsely depressed creatinine results and one falsely depressed carbon dioxide result were obtained on four patient sample using an advia 1800 analyzer.The customer contacted the siemens customer care center (ccc) and a siemens customer service engineer (cse) was dispatched to the customer's site and inspected the instrument.The issue originated when the cse initially identified a dilution tray wash unit (dwud) overflow and leak.The cse worked remotely with the customer to perform dwud maintenance but during the procedure, the customer hit the dwud to the dilution turn table tray (dtt) causing misalignment.The cse removed the dwud assembly and performed a dwud alignment to dtt position, returning the system to normal operation.Performing alignment is considered normal troubleshooting and/or maintenance for issues of this nature.System was fully operational upon departure.No further evaluation of the device is required.

• Brand Name: ADVIA 1800 ANALYZER
• Common Device Name: ADVIA 1800 ANALYZER
• 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: eric so ; 511 benedict ave.; tarrytown, NY 10591 ; 2012144764
• MDR Report Key: 18188338
• Report Number: 2432235-2023-00304
• Device Sequence Number: 6503888
• Product Code: JJE
• UDI-Device Identifier: 00630414534794
• UDI-Public: 00630414534794
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 11/22/2023

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 1800 ANALYZER
• Device Catalogue Number: 10315183
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 11/21/2023
• 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