MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA SOLUTION; ATELLICA CH 930

Model Number	ATELLICA CH 930
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted siemens to report that six falsely depressed digoxin (dgn) patient sample test results were obtained from an atellica ch 930 analyzer.Siemens reviewed the available data and found that the calibration for digoxin that was performed before the discordant patient samples were run had a shift in the raw data.The dilution probe was replaced and digoxin was recalibrated, resolving the issue.The cause of the falsely depressed digoxin (dgn) patient sample test results was the dilution probe.The instrument is performing within specifications.No further evaluation of this device is needed.
Event or Problem Description
Six falsely depressed digoxin (dgn) patient sample test results were obtained from an atellica ch 930 analyzer.The initial results were reported to the physician(s).The same patient samples were repeated on an alternate analyzer.The repeat results were higher and were reported to the physician(s) as the correct results.There are no known reports of patient intervention or adverse health consequences due to the falsely depressed dgn results.

• Brand Name: ATELLICA SOLUTION
• Common Device Name: ATELLICA CH 930
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 12256349
• Report Number: 2432235-2021-00196
• Device Sequence Number: 14393013
• Product Code: JJE
• UDI-Device Identifier: 00630414595863
• UDI-Public: 00630414595863
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K151767
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2021

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: ATELLICA CH 930
• Device Catalogue Number: 11067000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 07/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1