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

Model Number	ADVIA CHEMISTRY 1800
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	12/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Multiple falsely depressed patient results were obtained on multiple complete metabolic panel assays on an advia 1800 instrument.The initial results were not reported to physician(s).The same samples were repeated on an alternate advia 1800 instrument.The repeated results were reported, as the correct results, to the physician(s).The customer did not provide specific assays or results.The customer also indicated that there was a delay of two hours in processing urine drug screen tests due to running maintenance and quality control on the original instrument.There are no known reports of patient intervention or adverse health consequences due to this event.
Additional Manufacturer Narrative
A united states (us) customer reported multiple falsely depressed patient results were obtained on an advia 1800 instrument.Quality controls recovered acceptably on the day of the event.The customer reported that the dilution pipetting probe (dpp) had a drip/droplet on its tip.The customer indicated that dilution pipetting probe (dpp) did not appear bent or warp.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 cse performed dpp primes, replaced the dilution probe aspiration pump (dip) seals, and performed a wash.The customer also verified qc.The cause of the depressed patient results is unknown.Siemens is investigating the incident.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2022-00392 on 29dec2022.Additional information (11jan2023): the customer service engineer (cse) performed dilution pipetting probe (dpp) primes, replaced the dilution probe aspiration pump (dip) seals, and performed a wash 2, resolving the issue.System was fully operational upon departure.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: eric so ; 511 benedict ave; tarrytown, NY 10591 ; 9145243067
• MDR Report Key: 16067562
• Report Number: 2432235-2022-00392
• Device Sequence Number: 6234452
• 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,Followup
• Report Date (Section B): 01/26/2023

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 CHEMISTRY 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: 12/06/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 12/29/2022
• Supplement Report FDA Received Date: 01/26/2023
• Date Device Manufactured: 07/15/2012
• 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