MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH; ATELLICA CH A-LYTE INTEGRATED MULTISENSOR (IMT NA K CL)

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding two (2) falsely elevated potassium (k) results on a patient sample obtained on an atellica ch 930 analyzer.Siemens is investigating the event.
Event or Problem Description
Two (2) discordant falsely elevated potassium (k) results on a patient sample were obtained on an atellica ch 930 analyzer.The falsely elevated results were reported to the physician(s), and the results were questioned.Later, a new sample was drawn from the same patient and processed on a non-siemens system at an alternate facility.A lower result, considered correct, was obtained and reported to the physician(s).No corrected report was issued for the falsely elevated results.There are no known reports of patient intervention and adverse health consequences due to the falsely elevated potassium (k) results.
Additional Manufacturer Narrative
Additional information (02-jan-2024): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the information provided by the customer and the instrument data logs.Quality control (qc) recovered within the customer¿s acceptable ranges, and no issues were noted with the other patient samples, indicating that the potassium (k) assay was performing acceptably.The integrated multisensor technology (imt) calibrations recovered within specifications.Hsc concluded that the cause of the event is consistent with a sample-specific interferent or preanalytical variables.A potential product issue was not identified.The customer is operational.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.Initial mdr 2432235-2024-00344 was filed on 02-jan-2024.

• Brand Name: ATELLICA CH
• Common Device Name: ATELLICA CH A-LYTE INTEGRATED MULTISENSOR (IMT NA K CL)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; registration # 2517506; 500 gbc drive, po box 6101; newark DE 19714 6101
• Manufacturer Contact: linda barletta ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 18424455
• Report Number: 2432235-2024-00344
• Device Sequence Number: 12698514
• Product Code: CEM
• UDI-Device Identifier: 00630414596518
• UDI-Public: 00630414596518
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K222438
• 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): 01/22/2024

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 Expiration Date: 09/24/2024
• Device Model Number: N/A
• Device Catalogue Number: SMN 11099315
• Device Lot Number: 130014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 01/02/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown