MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CI ANALYZER; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number	10947347
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falsely elevated sodium (na) test results were obtained on nine patient samples from an atellica ci analyzer and stated that the results were reported and questioned by the physician(s).The customer performed repeat testing using the same samples on a dimension vista analyzer at their sister site and noted that the repeat results were considered correct, and the customer issued a corrected report.After noticing the shift in consecutive patient results, the customer stated they ran quality control materials for sodium, potassium and chloride and obtained results that exceeded the assay range, so they stopped reporting sodium, potassium and chloride.There are no known reports of patient intervention or adverse health consequences due to the event.
Additional Manufacturer Narrative
The customer reported falsely elevated sodium (na) test results were obtained on nine patient samples from an atellica ci analyzer and stated that the results were reported and questioned by the physician(s).Siemens assisted the customer with troubleshooting and was informed that the customer cleaned and replaced the integrated multisensor technology (imt) sensor twice and then discovered that the integrated multisensor technology (imt) diluent was empty despite the supplies overview screen saying there was 30% remaining.The imt diluent was replaced, and quality control materials were run with acceptable results.The analyzer is performing within specifications.No further evaluation of this analyzer is needed.Siemens initiated a field action and released urgent field safety notice (ufsn) asw25-01.A.Ous atellica ci integrated multisensor technology (imt) diluent volume error to impacted customers outside of the united states on november 01, 2024, and released urgent medical device correction (umdc) asw25-01.A.Us atellica ci integrated multisensor technology (imt) diluent volume error to impacted us customers on november 05, 2024.The ufsn / umdc informs the customer of atellica ci integrated multisensor technology (imt) diluent shortage.The umdc/ufsn provides instructions to customers that must be followed until a future version of software is available and has been installed on their systems.
Additional Manufacturer Narrative
The initial mdr 2432235-2024-00283 was submitted on 06-nov-2024.Corrected information (03-dec-2024): section g3/g4, date received by manufacturer, of the mdr was revised from 23-aug-2024 to 25-oct-2024.

• Brand Name: ATELLICA CI ANALYZER
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue,; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LIMITED; chapel lane, swords, co.; dublin ; EI
• Manufacturer Contact: karl aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9142550572
• MDR Report Key: 20622874
• Report Number: 2432235-2024-00283
• Device Sequence Number: 12601052
• Product Code: JJE
• UDI-Device Identifier: 00630414229553
• UDI-Public: (01)00630414229553
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2024

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: 10947347
• Device Catalogue Number: 10947347
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2024
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2432235-11/06/2024-006-C
• Patient Sequence Number: 1
• Patient Sex: Unknown