MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP SYPHILIS (SYPH); 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 03/19/2017

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 due to (b)(6) customs regulations.Siemens healthcare diagnostics is investigating.The ifu states in the interpretation of results section: "results should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." the ifu states in the limitations section: "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.".

Event Description

A (b)(6) advia centaur xp (b)(6) result was obtained for a patient sample.The patient sample was tested on three alternate methods and the results were reactive.A previous sample from the same patients was tested in (b)(6) 2016.The results were (b)(6) on the advia centaur xp (b)(6) assay and (b)(6) on the three alternate methods.The patient was considered (b)(6) for (b)(6) testing.The patient sample was tested at another laboratory on the advia centaur xp (b)(6) assay and the results were (b)(6).Patient treatment was not altered or prescribed.There was no report of adverse health consequences due to the discordant advia centaur xp (b)(6) results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2017-00118 on july 31, 2017.07/31/2017 additional information: the customer was not able to send the sample for additional testing due to argentinian customs regulations.Therefore, siemens is unable to determine the cause of the discordant result.The patient has a history of negative results with the advia centaur xp syphilis assay.Based on the information provided from the customer, siemens is unable to rule out a sample specific issue as the cause for the false negative result.The cause for the discordant syphilis (syph) results is unknown.The instrument is performing within specifications.No further evaluation of the device is required.The ifu states in the limitations section: 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.The ifu states in the summary and explanation section: "nontreponemal tests have poor sensitivity and specificity, and recombinant antigen-based treponemal tests have higher sensitivity and specificity than native antigen-based treponemal tests." the ifu states in the interpretation of results section: "results should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings.".

• Brand Name: ADVIA CENTAUR XP SYPHILIS (SYPH)
• Type of Device: SYPHILIS ASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; e. walpole MA 02032
• Manufacturer Contact: eiman sulieman ; 333 coney street; e. walpole, MA 02032 ; 5086604603
• MDR Report Key: 6529737
• MDR Text Key: 74067536
• Report Number: 1219913-2017-00118
• Device Sequence Number: 1
• Product Code: LIP
• Combination Product (y/n): N
• Reporter Country Code: AR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/01/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2017
• Device Model Number: N/A
• Device Catalogue Number: 10492493
• Device Lot Number: 39081030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2017
• Initial Date FDA Received: 04/28/2017
• Supplement Dates Manufacturer Received: 07/31/2017
• Supplement Dates FDA Received: 08/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1