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

Model Number N/A

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2015

Event Type  malfunction  

Event Description

(b)(6) advia centaur xp syphilis (syph) results were obtained for a patient sample during validation.One patient sample was tested on the rpr method and the result was reactive.The patient sample was tested on the fta-abs blood test (confirmatory test).The test resulted as reactive minimal.Patient treatment was not altered or prescribed.There was no report of adverse health consequences due to the (b)(6) advia centaur xp syphilis results.

Manufacturer Narrative

The cause for the (b)(6) 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 (b)(6) antibodies may be undetectable in some stages of the infection and in some clinical conditions.".

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2015-00031 on february 17, 2015.On 04/28/2015 additional information: the customer sent the patient sample to siemens healthcare diagnostics for further testing and investigation.However, the sample was received thawed.The sample was sent on gel packs instead of frozen on dry ice as per protocol.The patient sample was run on three lots of the adiva centaur (b)(6) reagent.The lot numbers were 128018, 128019, and 128021.The results were negative across the lots.This is the same observation as the customer.(b)(6) results (index): lot 128018: 0.15, lot 128019: 0.11, lot 128021: 0.07.Siemens was unable to determine the cause of the discordant results.The patient sample was not considered valid since the sample was received thawed.Historical information for the sample was not available.No further evaluation of the device is required.The ifu states in the specimen collection and handling section: "-freeze samples, devoid of red blood cells, at or below -20°c for longer storage.Do not store in a frost-free freezer.Thoroughly mix thawed samples and centrifuge before using.When 10 samples were subject to 6 freeze/thaw cycles, no clinically significant differences were observed.-package and label samples for shipment in compliance with applicable federal and international regulations covering the transport of clinical samples and etiological agents.Store samples stoppered at 2-8 degrees celsius upon arrival.If shipment is expected to exceed 7 days, ship specimens frozen.Samples maintained at room temperature up to 7 days or refrigerated up to 7 days demonstrated no qualitative differences.".

• Brand Name: ADVIA CENTAUR XP SYPHILIS (SYPH) ASSAY
• 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; e. walpole MA 02032
• Manufacturer Contact: eiman sulieman ; 333 coney street; e. walpole, MA 02032 ; 5086604603
• MDR Report Key: 4521030
• MDR Text Key: 5360439
• Report Number: 1219913-2015-00031
• Device Sequence Number: 1
• Product Code: LIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112343
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 01/30/2015

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: 12/15/2015
• Device Model Number: N/A
• Device Catalogue Number: 10492493
• Device Lot Number: 128021
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2015
• Initial Date FDA Received: 02/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/08/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/27/2014
• 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