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

Model Number	ADVIA CHEMISTRY 1800
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Falsley elevated concentrated carbon dioxide (co2_c) results were obtained on two patient samples on an advia chemsitry 1800 instrument.The discordant results were not reported to the physician(s).The samples were reprocessed on the original instrument and one of these samples was reprocessed on an alternate instrument.The lower repeat results were considered correct and were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the different co2_c results.
Additional Manufacturer Narrative
A united states customer contacted a siemens customer care center (ccc) and reported that falsely elevated concentrated carbon dioxide (co2_c) results were obtained on two patient samples on an advia chemistry 1800 instrument.All quality controls (qc's) were within range on the day of testing.The customer service engineer (cse) was dispatched to the customer's site.The cse inspected the system and found nozzle #2 on the dilution reaction tray wash unit (dwud) was clogged.The cse removed, cleaned, and flushed nozzle assembly.Additionally, as a proactive measure, the cse cleaned and tested all the dwud nozzles and lines and tested for any restrictions; the cse did not find any.Then, the cse performed a wash, and the instrument ran without any issue.The calibrations and qc were run, which passed.The customer placed 10 patient samples and ran replicates for co2_c, and no issues/errors were observed.All tests were within specifications.Siemens further investigated the issue and determined that potential cause of the different co2_c results was instrument related.The instrument is performing according to specifications.No further evaluation of the 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 - 8558; JA 196 -8558
• Manufacturer Contact: christina lam ; 511 benedict avenue; tarrytown, NY 10591 ; 1942550090
• MDR Report Key: 15190224
• Report Number: 2432235-2022-00217
• Device Sequence Number: 5566262
• 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): 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): 08/09/2022

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 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: 07/15/2022
• Initial Report FDA Received Date: 08/09/2022
• 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