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	05/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A (b)(6) customer contacted a siemens customer care center (ccc).The advia 1800 chemistry system gave a dilution probe (dpp) error at the time of the event.The dpp detected liquid in the area above the sample container.A siemens customer service engineer (cse) was dispatched to the customer site.The cse performed a probe alignment and tightened all the screws on the sensor.The cse then ran quality controls (qc) which recovered in range.The system was functional upon the cse's departure.Siemens is investigating the issue.
Event or Problem Description
A discordant, falsely low creatinine (crea) result and carbon dioxide (co2) result were obtained on a patient sample on an advia 1800 chemistry system.The discordant results were reported to the physician(s).The patient sample was repeated for crea and co2 on the same instrument.The repeat results were higher than the discordant results.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 discordant results.
Additional Manufacturer Narrative
Siemens filed the initial mdr on 03-jun-2022.Additional information (08-jun-2022): after the customer service engineer (cse) realigned the dilution probe (dpp), no additional dpp errors occurred and no further issues were observed.The customer has continued to run samples on the analyzer and has had no other incidents related to this issue.The issue was resolved by the cse's service.The cause of the event was improper alignment of the dpp probe.The investigation findings and investigation conclusions codes in section h6 were updated to reflect this information.The system is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA 1800 CHEMISTRY SYSTEM
• Common Device Name: ADVIA 1800 CHEMISTRY SYSTEM
• 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: christopher aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 14595324
• Report Number: 2432235-2022-00169
• Device Sequence Number: 1996856
• Product Code: JJE
• UDI-Device Identifier: 00630414534794
• UDI-Public: 00630414534794
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2022

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): Follow-Up
• Initial Date Received by Manufacturer: 05/11/2022
• Supplement Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 06/03/2022
• Supplement Report FDA Received Date: 07/01/2022
• 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