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

Model Number	ATELLICA CH 930
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted siemens to report that a discordant, falsely depressed potassium test result was obtained from an atellica ch 930 instrument.A siemens customer service engineer (cse) was dispatched to the customer site to inspect the instrument.The cse put the instrument into the diagnostics mode and inspected the integrated multi-sensor technology (imt) module assembly to verify all the connections to the module were tight.The cse primed the imt module to verify proper fluid flow and found there were no restrictions.The cse ran the check 1 on the imt and quality control materials with acceptable results.The cause of the discordant, falsely depressed potassium test result is unknown.The instrument is performing within specifications.No further investigation of this instrument is needed.
Event or Problem Description
A discordant, falsely depressed potassium test result was obtained from an atellica ch 930 instrument.The initial result was flagged with a delta check error and not reported to the physician(s).The same sample was repeated and reported as the correct result to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed potassium test result.

• Brand Name: ATELLICA SOLUTION
• Common Device Name: ATELLICA SOLUTION
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown, ny
• MDR Report Key: 9993577
• Report Number: 2432235-2020-00277
• Device Sequence Number: 14573674
• Product Code: JJE
• UDI-Device Identifier: 00630414596518
• UDI-Public: 00630414596518
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151767
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/23/2020

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: 03/31/2020
• Initial Report FDA Received Date: 04/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1