MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP SYPHILIS; SYPHILIS ASSAY

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	05/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause for the discordant (b)(6) results is unknown.The patient sample is not available for additional testing at the manufacturer's site.Siemens healthcare diagnostics is unable to determine root cause.The appears to be a sample specific issue.The interpretation of results section of the instructions for use (ifu) state: "results should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." the limitations section of the ifu states: "a nonreactive test result does not exclude the possibility of exposure to or infection with syphilis.T.Pallidum antibodies may be undetectable in some stages of the infection and in some clinical conditions.Assay performance characteristics have not been established when the advia centaur syph assay is used in conjunction with other manufacturers' assays for specific syphilis serological markers." the advia centaur syphilis (syph) ifu (10632392 rev.F, 2016-04 ous) states "the initial sensitivity of the advia centaur syph assay compared to reference assay 1 was 98.0% (700/714) with a 95% confidence interval of 96.7-98.9%.The advia centaur syphilis (syph) ifu (10632391 rev.F, 2016-04 us) states "the negative percent agreement of the advia centaur syph assay compared to the comparative assay was 98.4% (568/577) with a 95% confidence interval (ci) of 97.1 to 99.3%.".
Event or Problem Description
Customer observed a (b)(6) advia centaur xp (b)(6) result for a sample that was (b)(6) by other methods.There are not reports that treatment was altered or prescribed or adverse health consequences due to the (b)(6) advia centaur xp (b)(6) result.

• Brand Name: ADVIA CENTAUR XP SYPHILIS
• Common Device Name: SYPHILIS ASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; tarrytown NY 10591
• MDR Report Key: 6631081
• Report Number: 1219913-2017-00140
• Device Sequence Number: 1049356
• Product Code: LIP
• UDI-Device Identifier: 00630414580173
• UDI-Public: 00630414580173
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K112343
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 06/09/2017

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 Expiration Date: 09/09/2017
• Device Model Number: N/A
• Device Catalogue Number: 10492493
• Device Lot Number: 11095033
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2017
• Initial Report FDA Received Date: 06/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1