MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP HBSAGII CONFIRMANTORY (CONF) ASSAY; HBSAG CONFIRMATORY IMMUNOASSAY

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A siemens customer service engineer (cse) was sent to the customer's site for system inspection.The cse replace the aspirate probe/wash guide service kit, 2 way valve and 3 way valve service kits, and tubing.The assay was recalibrated, and the cse performed a precision check with quality control material with acceptable results.The cause for the (b)(6) result obtained on a diluted (b)(6) patient sample is unknown.There is no patient sample available for further testing.No conclusion can be drawn.The (b)(6) instruction for use (ifu) in the results section states the following: "samples reported as redilute require further dilution for confirmation." cse precision check: (b)(6) qc precision check results: (b)(6).Havt qc precision check results: (b)(6).The instrument is performing within specifications.No further evaluation of the device is required.
Event or Problem Description
A (b)(6) result was obtained on a dilution (b)(6) patient sample.The customer observed with a re-dilute flag when (b)(6) testing was initially performed, however prior to diluting the sample for (b)(6) testing, the sample was run neat confirming the (b)(6) results.There are no reports that treatment was altered or prescribed or adverse health consequences due to the (b)(4) diluted (b)(6) result.

• Brand Name: ADVIA CENTAUR XP HBSAGII CONFIRMANTORY (CONF) ASSAY
• Common Device Name: HBSAG CONFIRMATORY IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 7318836
• Report Number: 1219913-2018-00098
• Device Sequence Number: 18859512
• Product Code: LOM
• UDI-Device Identifier: 00630414472874
• UDI-Public: 00630414472874
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P030049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/07/2019
• Device Model Number: N/A
• Device Catalogue Number: 10309058
• Device Lot Number: 3119
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2018
• Initial Report FDA Received Date: 03/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1