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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/14/2017

Event Type  malfunction  

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 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
• Type of Device: SYPHILIS ASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC; 333 coney street; east walpole MA 02032
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 5086604381
• MDR Report Key: 6631081
• MDR Text Key: 77619183
• Report Number: 1219913-2017-00140
• Device Sequence Number: 1
• Product Code: LIP
• UDI-Device Identifier: 00630414580173
• UDI-Public: 00630414580173
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112343
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1