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

Catalog Number	SMN 11099315
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A discordant falsely elevated potassium (k) patient sample result was obtained on an atellica ® ch 930 analyzer.The falsely elevated result was reported to the physician and was questioned.The same sample was reprocessed on two alternate non-siemens instruments and obtained falsely elevated results.The patient returned to the emergency room (er) and was redrawn.The new sample was processed on two alternate non-siemens instruments and recovered lower results.A corrected report was issued.There are no known reports of patient intervention or adverse health consequences due to the falsely elevated potassium (k) result.
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding a falsely elevated potassium (k) patient result obtained on an atellica ® ch 930 analyzer.Siemens healthcare diagnostics headquarters support center (hsc) reviewed the information provided by the customer and the instrument data logs.Quality control recovered within the customer's expectation.Sample with falsely elevated result was tested on an alternate non-siemens instrument and potassium recovery was also elevated indicating falsely elevated potassium is sample related.Hsc concluded that the cause of the event is consistent with preanalytical variables.The customer is fully operational.The device is performing according to specifications.No further evaluation is required.

• 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 ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive po box 6101; registration # 2517506; newark DE 19714 6101
• Manufacturer Contact: linda barletta ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 17842528
• Report Number: 2432235-2023-00264
• Device Sequence Number: 4312533
• Product Code: CEM
• UDI-Device Identifier: 00630414596518
• UDI-Public: 00630414596518
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2023

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 Expiration Date: 10/31/2023
• Device Catalogue Number: SMN 11099315
• Device Lot Number: 120012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/04/2023
• Initial Report FDA Received Date: 09/29/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown