MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP HBSAG CONFIRMATORY (CONF) ASSAY; HBSAG CONFIRMATORY 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 04/19/2018

Event Type  malfunction  

Manufacturer Narrative

The customer does not know what the expected result should be for the patient sample.The customer requested a redraw sample but no other information was received.The sample tube type is serum gel tube.The spin time is 15 minutes at 2500 rpm.The siemens technical application specialist (tas) reran the sample in question for (b)(6) in replicates of five to check for imprecision.The results were (b)(6).The cause for the discordant advia centaur xp hbsag conf results is unknown.Siemens healthcare diagnostics is investigating.The ifu states in the results section: "the system reports advia centaur hbsag confirmatory results as invalid, redilute, not confirmed, or confirmed: -samples are reported as invalid if the sample run with reagent b is below the cutoff value of the advia centaur hbsag confirmatory assay.The assay is invalid and should be repeated.If the interpretation is invalid after repeat testing, it means a valid result cannot be obtained with this sample and a new sample should be obtained.-samples reported as redilute require further dilution for confirmation.-samples reported as not confirmed are hbsag negative.-samples reported as confirmed are hbsag positive." the hbsag conf assay ifu states in the limitations section: "for diagnostic purposes and to differentiate between acute and chronic hbv infection, the detection of hbsag should be correlated with patient clinical information and other hbv serological markers.It is recognized that current methods for detection of hepatitis b surface antigen may not detect all potentially infected individuals.A false reactive hbsag test result or invalid confirmatory result does not exclude the possibility of exposure to or infection with hepatitis b.".

Event Description

A not confirmed advia centaur xp hbsag confirmatory (conf) result was obtained on a patient sample when run with a dilution of 50.The result was questioned since the neat testing with the advia centaur xp hbsag confirmatory was invalid on two systems and testing with the (b)(6) assay was repeat (b)(6).The customer sent the sample to another site for (b)(6) dna testing and the result was (b)(6).Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant (b)(6) confirmatory result.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2018-00149 on may 16, 2018.05/31/2018 additional information: the customer's procedure is to collect a new sample after obtaining (b)(6) with (b)(6)confirmatory assay.However, it is unknown when the new sample will be available for retesting with advia centaur hbsagii assay.The patient sample resulted as (b)(6) which means the presence of (b)(6) was not found.The testing algorithm provided in the advia centaur xp hbsagii (10635153_en rev.G, 2017-12) and advia centaur xp hbsag confirmatory (10997052_en rev.T, 2016-11) was followed and provided the correct result.The advia centaur xp hbsagii ifu states under limitations section that "heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays.Patients routinely exposed to animals or to animal serum products can be prone to this interference and anomalous values may be observed.Additional information may be required for diagnosis." the customer is satisfied with the provided information.The instrument is performing within specifications.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR XP HBSAG CONFIRMATORY (CONF) ASSAY
• Type of Device: HBSAG CONFIRMATORY IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 7520416
• MDR Text Key: 108494190
• Report Number: 1219913-2018-00149
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 00630414472874
• UDI-Public: 00630414472874
• Combination Product (y/n): N
• PMA/PMN Number: P030049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2019
• Device Model Number: N/A
• Device Catalogue Number: 03393818
• Device Lot Number: 3119
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1