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	10/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
An atellica ch 930 instrument generated a lipemic index value of 0 on a patient sample.The sample was visually inspected by the operator and was rated as having a lipemic index of 4.The same sample was reportedly tested for triglyceride, sodium and potassium.The sample was repeat tested for sodium and potassium using an alternate instrument.There are no known reports of patient intervention or adverse health consequences due to the lipemic index.
Additional Manufacturer Narrative
An outside the united states customer contacted siemens to report that an atellica ch 930 instrument generated a lipemic index value of 0 on a patient sample.Siemens evaluated the instrument's photometer data and found the instrument is working as specified.The lipemic index does not correlate with visual inspection or triglycerides concentration.The lipemic index is solely designed to detect interference with assays.The lipemia index is a measure of photometric light scatter.The cause of the lipemic index not matching a visual inspection is that the lipemic index does not directly correlate to a visual inspection.The instrument is performing within specification.No further evaluation of this instrument is needed.

• Brand Name: ATELLICA SOLUTION
• Common Device Name: ATELLICA CH 930
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; registration #: 2247117; flanders NJ 07836
• Manufacturer Contact: karl aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9142550572
• MDR Report Key: 12763124
• Report Number: 2432235-2021-00271
• Device Sequence Number: 11598813
• Product Code: JJE
• UDI-Device Identifier: 00630414596495
• UDI-Public: 00630414596495
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K151767
• 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): 11/05/2021

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 11/07/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown