MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CHEMISTRY XPT

Model Number	ADVIA CHEMISTRY XPT
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A siemens customer service engineer (cse) was dispatched to the customer site to inspect the advia chemistry xpt instrument.The cse analyzed the instrument and replaced the spectrophotometer lamp.The cse returned the instrument to an operational status.The cause of the discordant creatinine (cre_2c) test result on multiple samples was the spectrophotometer lamp malfunction.The instrument is performing within specifications.No further evaluation of this device is required.
Event or Problem Description
Discordant creatinine (cre_2c) test results were obtained on multiple samples on an advia chemistry xpt instrument.The initial results were reported to the physician(s).The same samples were repeated on the same advia chemistry xpt instrument and corrected reports were provided to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant creatinine test results.

• Brand Name: ADVIA CHEMISTRY XPT
• Common Device Name: ADVIA CHEMISTRY XPT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 7389053
• Report Number: 2432235-2018-00113
• Device Sequence Number: 11097618
• Product Code: JJE
• UDI-Device Identifier: 00630414553184
• UDI-Public: 00630414553184
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K990346
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/02/2018

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: ADVIA CHEMISTRY XPT
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2018
• Initial Report FDA Received Date: 04/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1