MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH 930 CHEMISTRY INSTRUMENT

Model Number	ATELLICA CH 930
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) to report that a falsely high glucose (gluh_3) test result was obtained on the atellica ch 930 chemistry instrument.A siemens customer service engineer (cse) was dispatched to the site to inspect the instrument.The cse checked the alignment of the reagent mixer (rmix), the alignment of the cuvette washer probe height, performed a functional test of rmix module, checked the alignment (including radial arm alignment) of the reagent 2 (r2) mechanism, the alignment of the sample mixer (smix) and ran a precision study after the alignments were checked.The cause of the discordant, falsely high glucose (gluh_3) test result is unknown.The device is performing within manufacturing specifications.No further evaluation of the device is required.
Event or Problem Description
A discordant, falsely high glucose (gluh_3) test result was obtained from an atellica ch 930 chemistry instrument.The same sample was repeated automatically on the same instrument giving a lower test result.The initial result was not reported to the physician(s).The repeat result was reported to the physician(s) and is considered correct.There are no known reports of patient intervention or adverse health consequences due to the discordant falsely high glucose (gluh_3) test result.

• Brand Name: ATELLICA CH 930 CHEMISTRY INSTRUMENT
• Common Device Name: ATELLICA CH 930
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 8028667
• Report Number: 2432235-2018-00401
• Device Sequence Number: 13503718
• Product Code: JJE
• UDI-Device Identifier: 00630414596488
• UDI-Public: 00630414596488
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K151767
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2018

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2018
• Initial Report FDA Received Date: 11/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1