MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC ADVIA 1800

Model Number	ADVIA 1800
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted a siemens customer care center (ccc) and reported falsely depressed concentrated calcium_2 (ca_2c) results were obtained on a patient sample on an advia 1800 instrument.Quality controls recovered within acceptable ranges on the day of the event.Siemens customer service engineer (cse) was dispatched to the customer's site.The cse inspected all the probes and dilution mixer, checked the wash probe aspirate dispense, and verified dilution reaction tray wash unit (dwud) operation and probe alignments.Then, the cse replaced all the pump seals related to the dilution probe (dpp) as it was suspected that there was an issue with the initial dilution of the sample in questions.The cse observed that the lamp energies were low, and the lamp was changed.The cse performed a wash 2 and the cell blank.Energies and blank values returned to normal.Then, the customer ran calibration and quality control (qc) which recovered acceptably.The cause of the falsely depressed ca_2c results is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A falsely depressed concentrated calcium_2 (ca_2c) patient sample result was obtained on an advia 1800 instrument.The discordant result was reported to the physician(s), who questioned the result.The sample was repeated, and the sample recovered similarly.Based on these depressed results, the patient was sent to the emergency room, where the lab processed the same patient sample again.The second repeat result was higher than the discordant results.The higher repeat 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 ca_2c results.

• Brand Name: ADVIA 1800
• Common Device Name: ADVIA 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: kristin kehyaian ; 511 benedict ave; tarrytown, NY 10591 ; 9148267101
• MDR Report Key: 15008755
• Report Number: 2432235-2022-00198
• Device Sequence Number: 14082800
• Product Code: JJE
• UDI-Device Identifier: 00630414534794
• UDI-Public: 00630414534794
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/13/2022

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
• 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: 06/20/2022
• Initial Report FDA Received Date: 07/13/2022
• 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