MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP HAV TOTAL (AHAVT); HAVT IMMUNOASSAY

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 09/08/2015

Event Type  malfunction  

Manufacturer Narrative

The cause of the discordant advia centaur xp (b)(6) result is unknown.Siemens has requested the sample for investigation.Us instructions for use intended use section states: "the (b)(6) assay is indicated as an aid in the diagnosis of previous or ongoing (b)(6) or in the identification of hav-susceptible individuals for vaccination." ous instructions for use intended use section states: "as assay for (b)(6) is indicated as an aid in the diagnosis of previous or ongoing , or for the detection of (b)(6) after vaccination.".

Event Description

Customer observed a result that is repeatedly (b)(6) with advia centaur xp hav total (ahavt) assay.The patient is (b)(6) by and alternate method and pcr.The patient had several blood draws that are (b)(6) on the advia centaur xp ahavt assay and (b)(6) by other methods.There are no reports that treatment was altered or prescribed or adverse health consequences due to the (b)(6) advia centaur xp (b)(6) result.

Manufacturer Narrative

Mdr 1219913-2016-00047 was filed on february 10, 2016 reporting a result that was repeatedly (b)(6) with the advia centaur xp hav total (ahavt) assay.The patient was (b)(6) by an alternate method and pcr.April 4, 2016 - additional information: the customer provided the ahavt lot number as 073177 expiration date september 28, 2016.Siemens received the sample and performed the following testing.The sample was tested with advia centaur hav total reagent lot 104072 both neat and after treatment with an hbt tube.Neat sample (b)(6).Treated sample (b)(6).The sample was tested with advia centaur hav igm reagent lots 070164 and 070165 both neat and after treatment with an nabt tube.Reagent lot 070164 neat sample >assay range (b)(6).Treated sample >assay range (b)(6).Reagent lot 070165 neat sample >assay range (b)(6).Treated sample >assay range (b)(6).These results indicate the issue is specific to this sample or patient.The limitations section of the us instructions for use for hav total states: "the results from this or any other diagnostic kit should be used and interpreted only in the context of the overall clinical picture.A nonreactive test result does not exclude the possibility of exposure to hepatitis a virus.".

• Brand Name: ADVIA CENTAUR XP HAV TOTAL (AHAVT)
• Type of Device: HAVT IMMUNOASSAY
• 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: 5464010
• MDR Text Key: 39210064
• Report Number: 1219913-2016-00047
• Device Sequence Number: 1
• Product Code: LOL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P040017
• 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,Followup
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 05498862
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2016
• Was Device Evaluated by Manufacturer?: No
• 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