MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT ANTI-HBS2 (AHBS2) ASSAY; AHBS IMMUNOASSAY

Model Number N/A

Device Problem False Positive Result (1227)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/15/2020

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc) to report (b)(6) advia centaur xpt (b)(6) results from the same patient.Siemens is investigating the event and has requested patient information and sample availability.Mdr 1219913-2020-00196, and mdr 1219913-2020-00198 were filed for the same patient and event.

Event Description

(b)(6) advia centaur xpt (b)(6) results were obtained by the customer on the same patient and considered (b)(6) compared to a (b)(6) alternate (b)(6) test method result.The (b)(6) alternate (b)(6) test method result was reported to the physician(s) as the corrected result.There are no reports that treatment was altered or prescribed or adverse health consequences due to the (b)(6) advia centaur xpt (b)(6) results.

Manufacturer Narrative

Mdr 1219913-2020-00197 was filed on 05-aug-2020 regarding a false positive advia centaur xpt anti-hbs2 (ahbs2) result that was discordant compared to a negative alternate anti-hbs test method result.(b)(6) 2020 additional information: the customer had a sample ((b)(6)) from a patient that recovered reactive (40.5, 43.94 miu/ml) with advia centaur xpt anti-hbs2 (ahbs2) lot 124 but when the sample was tested with an alternate method anti-hbs assay it was nonreactive.The sample was also hbsii reactive (2.37, 2.49 index) and hbct nonreactive (<0.07 index).Another sample (0140716114) from the same patient was reactive (36.92 miu/ml) with advia centaur xpt ahbs2, this sample was also hbsii reactive (1.74 index).There is no sample that can be sent to siemens for evaluation.The samples were from dry tubes and were not tested on any other reagent lot except advia centaur ahbs2 lot 124.The customer was not able to provide the patient's medical status or a list of medications/supplements the patient was taking.The patient has not been vaccinated for hepatitis b.The patient has not been vaccinated for hepatitis b.When the customer treated the 2nd sample (0140716114) with a heterophilic blocking tube (hbt) the ahbs2 result became nonreactive (8.37 and 6.23 miu/ml) but the hbsii result stayed reactive (1.58 index).Based on the hbt instructions for use (ifu) the hbt is designed to block heterophilic interference where a serum or plasma sample contains antibodies which are able to bind to animal antibodies used in immunochemistry assays.The advia centaur xpt ahbs2 assay architecture does not include animal antibodies, it uses inactivated human hepatitis b surface antigen and recombinant hepatitis b surface antigen.Since the assay architecture does not include animal antibodies, heterophilic interference is not causing the reactive results with the advia centaur xpt ahbs2 assay.When the customer treated the 2nd sample with a non-specific antibody blocking tube (nabt) the ahbs2 result became nonreactive (5.11 miu/ml) and hbsii generated one reactive result and one nonreactive result (1.01 and 0.72 index).Based on the nabt ifu the nabt is designed to block non-specific antibody interference where a serum or plasma sample contains antibodies which are able to bind non-specifically in an immunoassay.An anti-human antibody in the immunoassay then binds the non-specifically bound antibody creating a false positive result.The advia centaur xpt ahbs2 assay architecture does not include anti-human antibodies.Since the assay architecture does not contain anti-human antibodies, non-specific antibody interference is not causing the reactive results with the advia centaur xpt ahbs2 assay.It is possible that something in the tubes is binding something in the sample that is interfering with the advia centaur xpt ahbs2 and hbsii assays but siemens cannot say what the interferent is.The clinical sensitivity and specificity section of the advia centaur xp/xpt anti-hbs2 ifu (10629819, revision l, 2019-08) lists the 95% confidence interval (ci) for resolved relative specificity as 98.34% - 99.88% so a certain number of false positive results can be expected for this assay.The false positive results from this one patient do not indicate a product problem with the advia centaur xpt ahbs2 assay.The cause of the discrepant results seen by the customer with samples from this one patient when using the advia centaur xpt ahbs2 assay could not be determined but hsc cannot rule out pre-analytical factors, a sample issue, or normal assay performance.Based on the investigation, no product problem was identified.Mdr 1219913-2020-00196 supplemental 1 and mdr 1219913-2020-00198 supplemental 1 were filed for the same event.In section h6, the health effect - clinical code and the component code were added.The medical device problem code and the type of investigation codes remained the same.The investigation findings code and the investigation conclusions codes were revised.Esubmitter would not allow a selection of a health effect - impact code but 2199- no health consequence or impact is used for this event.

• Brand Name: ADVIA CENTAUR XPT ANTI-HBS2 (AHBS2) ASSAY
• Type of Device: AHBS IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 10370709
• MDR Text Key: 240122392
• Report Number: 1219913-2020-00197
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 00630414561790
• UDI-Public: 00630414561790
• Combination Product (y/n): N
• PMA/PMN Number: P100039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2021
• Device Model Number: N/A
• Device Catalogue Number: 10286268
• Device Lot Number: 124
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 22 YR