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

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/11/2019

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant elevated advia centaur xp ahbs2 results is unknown.Siemens healthcare diagnostics is investigating.This report was filed for the sample tested on (b)(6) 2019 on advia centaur xp 1.Mdr 1219913-2019-00149 was filed for the sample tested on (b)(6) 2019 on advia centaur xp 2.Mdr 1219913-2019-00150 was filed for the sample tested on (b)(6) 2019 on advia centaur xp 1.Mdr 1219913-2019-00151 was filed for the sample tested on (b)(6) 2019 on advia centaur xp 2.Mdr 1219913-2019-00152 was filed for the sample tested on (b)(6) 2019 on advia centaur xp 3.

Event Description

Customer observed reproducible elevated results on two samples from the same patient with the advia centaur xp anti-hbs2 (ahbs2) assay that did not agree with historical results or results from two alternate methods.There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated advia centaur xp ahbs2 results.This report was filed for the sample tested on (b)(6) 2019 on advia centaur xp 1.Mdr 1219913-2019-00149 was filed for the sample tested on (b)(6) 2019 on advia centaur xp 2.Mdr 1219913-2019-00150 was filed for the sample tested on (b)(6) 2019 on advia centaur xp 1.Mdr 1219913-2019-00151 was filed for the sample tested on (b)(6) 2019 on advia centaur xp 2.Mdr 1219913-2019-00152 was filed for the sample tested on (b)(6) 2019 on advia centaur xp 3.

Manufacturer Narrative

Siemens filed mdrs on august 5, 2019 reporting that the customer observed reproducible elevated results on two samples from the same patient with the advia centaur xp anti-hbs2 assay that did not agree with historical results or results from two alternate methods.Supplemental reports were filed on september 9, 2019 reporting that the sample had been received by siemens for testing.October 8, 2019 - additional information: siemens received the information from the customer indicating that ahbs2 results in the patient's medical records from 2017 were nonreactive and less than 10 miu/ml.Siemens tested the sample with reagent lot 104 and reactive results were observed while nonreactive with another lot of ahbs2 reagents.Siemens continues to investigate.The customer noted that they have another sample from the same patient that has been sent to siemens.This sample had an ahbs2 value of 239 miu/ml and hbsag >1000 index.The patient has hormone injections every three months but no details regarding the injection are available at this time.Siemens continues to investigate.Mdr 1219913-2019-00148, mdr 1219913-2019-00148 supplemental 1, and mdr 1219913-2019-00148 supplemental 2 were filed for the sample tested on july 11, 2019 on advia centaur xp 1.Mdr 1219913-2019-00149, mdr 1219913-2019-00149 supplemental 1, and mdr 1219913-2019-00149 supplemental 2 were filed for the sample tested on july 11, 2019 on advia centaur xp 2.Mdr 1219913-2019-00150, mdr 1219913-2019-00150 supplemental 1, and mdr 1219913-2019-00150 supplemental 2 and mdr 1219913-2019-00150 supplemental 1 were filed for the sample tested on july 18, 2019 on advia centaur xp 1.Mdr 1219913-2019-00151, mdr 1219913-2019-00151 supplemental 1, and mdr 1219913-2019-00151 supplemental 2 were filed for the sample tested on july 18, 2019 on advia centaur xp 2.Mdr 1219913-2019-00152, mdr 1219913-2019-00152 supplemental 1, and mdr 1219913-2019-00152 supplemental 2 were filed for the sample tested on july 18, 2019 on advia centaur xp 3.

Manufacturer Narrative

Siemens filed mdrs on august 5, 2019 reporting that the customer observed reproducible elevated results on two samples from the same patient with the advia centaur xp anti-hbs2 assay that did not agree with historical results or results from two alternate methods.Supplemental reports were filed on september 9, 2019 reporting that the sample had been received by siemens for testing and october 8, 2019 reporting additional information regarding the patient and siemens testing.November 8, 2019 - additional information: the customer noted that they have another sample from the same patient on (b)(6) 2019 that has been sent to siemens.This sample had an ahbs2 value of 239 miu/ml with advia centaur ahbs2 reagent lot 116 and hbsag >1000 index with advia centaur hbsagii reagent lot 192.The new result was not reported to the physician.The patient has hormone injections (medroxyprogesterone acetate) every three months.Siemens has received the sample and is using it to investigate why the samples from this patient are reactive with some lots of advia centaur ahbs2 and non-reactive with other lots.Siemens continues to investigate.Mdr 1219913-2019-00148, mdr 1219913-2019-00148 supplemental 1, mdr 1219913-2019-00148 supplemental 2 and mdr 1219913-2019-00148 supplemental 3 were filed for the sample tested on july 11, 2019 on advia centaur xp 1.Mdr 1219913-2019-00149, mdr 1219913-2019-00149 supplemental 1, mdr 1219913-2019-00149 supplemental 2 and mdr 1219913-2019-00149 supplemental 3 were filed for the sample tested on july 11, 2019 on advia centaur xp 2.Mdr 1219913-2019-00150, mdr 1219913-2019-00150 supplemental 1, mdr 1219913-2019-00150 supplemental 2 and mdr 1219913-2019-00150 supplemental 3 were filed for the sample tested on july 18, 2019 on advia centaur xp 1.Mdr 1219913-2019-00151, mdr 1219913-2019-00151 supplemental 1, mdr 1219913-2019-00151 supplemental 2 and mdr 1219913-2019-00151 supplemental 3 were filed for the sample tested on july 18, 2019 on advia centaur xp 2.Mdr 1219913-2019-00152, mdr 1219913-2019-00152 supplemental 1, mdr 1219913-2019-00152 supplemental 2 and mdr 1219913-2019-00152 supplemental 3 were filed for the sample tested on july 18, 2019 on advia centaur xp 3.

Manufacturer Narrative

Siemens filed mdrs reporting that the customer observed reproducible elevated results on two samples from the same patient with the advia centaur xp anti-hbs2 assay that did not agree with historical results or results from two alternate methods.September 9, 2019 - additional information siemens received the sample and is in the process of testing the sample and evaluating the results.Mdr 1219913-2019-00148 and mdr 1219913-2019-00148 supplemental 1 were filed for the sample tested on (b)(6) 2019 on advia centaur xp 1.Mdr 1219913-2019-00149 and mdr 1219913-2019-00149 supplemental 1 were filed for the sample tested on (b)(6) 2019on advia centaur xp 2.Mdr 1219913-2019-00150 and mdr 1219913-2019-00150 supplemental 1 were filed for the sample tested on (b)(6) 2019 on advia centaur xp 1.Mdr 1219913-2019-00151 and mdr 1219913-2019-00151 supplemental 1 were filed for the sample tested on (b)(6) 2019 on advia centaur xp 2.Mdr 1219913-2019-00152 and mdr 1219913-2019-00152 supplemental 1 were filed for the sample tested on (b)(6) 2019 on advia centaur xp 3.

Manufacturer Narrative

Siemens filed mdrs on august 5, 2019 reporting that the customer observed reproducible elevated results on two samples from the same patient with the advia centaur xp anti-hbs2 assay that did not agree with historical results or results from two alternate methods.Supplemental reports were filed on september 9, 2019 reporting that the sample had been received by siemens for testing and october 8, 2019 reporting additional information regarding the patient and siemens testing.An additional supplemental report was filed on december 2, 2019 with additional information from the customer.March 27, 2020: additional information: the customer had a patient sample that recovered reactive (serum 340, 352 miu/ml; plasma 605, 591, 627 miu/ml) with advia centaur xp anti-hbs2 (ahbs2) lot: 104 but nonreactive with an alternate anti-hbs assay.The patient's medical record from 2017 indicated that the advia centaur ahbs2 ahbs2 results were nonreactive and less than 10 miu/ml.The patient was also advia centaur xp hbsii reactive (1000 index), hbeag reactive (1000 index), ahbe nonreactive (0 index), chiv nonreactive, ahavt reactive (100 u/ml).Siemens' testing was able to duplicate what the customer saw with reagent lot: 104 but the sample is nonreactive with another ahbs2 lot.The additional sample provided by the customer was investigated further but siemens has not been able to determine the reason for the reactive results with certain advia centaur ahbs2 lots.Testing suggests the reactive result is caused by non-specific binding to a component of the solid phase reagent.Siemens was not able to determine if the reactive result was due to human igg.Siemens sourced patients samples from asia, europe, and the united states but we were not able to find more samples that perform similar to samples from this patient with the advia centaur ahbs2 assay.The clinical sensitivity and specificity section of the advia centaur xp/xpt anti-hbs2 instructions for use (ifu) (10629819, revision k, 2017-12) lists the 95% confidence interval (ci) for resolved relative specificity as 98.34% - 99.88% so a certain number of false reactive results can be expected for this assay.This 1 false positive patient does not indicate a product problem with advia centaur xp ahbs2 lot: 104.A review of internal data and field data indicates advia centaur xp ahbs2 lot: 104 is performing as intended.The specific cause of the reactive result seen by the customer when using advia centaur xp ahbs2 lot: 104 could not be determined but was due to an interaction with something in this specific sample.Based on the investigation, no product problem was identified.Section h6 results and conclusion code was updated to reflect the additional information.Mdr 1219913-2019-00148 supplemental 1, mdr 1219913-2019-00148 supplemental 2.Mdr 1219913-2019-00148 supplemental 3 and mdr 1219913-2019-00148 supplemental 4 were filed for the sample tested on july 11, 2019 on advia centaur xp 1.Mdr 1219913-2019-00149, mdr 1219913-2019-00149 supplemental 1, mdr 1219913-2019-00149 supplemental 2, mdr 1219913-2019-00149 supplemental 3 and mdr 1219913-2019-00149 supplemental 4 were filed for the sample tested on july 11, 2019 on advia centaur xp 2.Mdr 1219913-2019-00150, mdr 1219913-2019-00150 supplemental 1, mdr 1219913-2019-00150 supplemental 2, mdr 1219913-2019-00150 supplemental 3 and mdr 1219913-2019-00150 supplemental 4 were filed for the sample tested on july 18, 2019 on advia centaur xp 1.Mdr 1219913-2019-00151, mdr 1219913-2019-00151 supplemental 1, mdr 1219913-2019-00151 supplemental 2, mdr 1219913-2019-00151 supplemental 3 and mdr 1219913-2019-00151 supplemental 4 were filed for the sample tested on july 18, 2019 on advia centaur xp 2.Mdr 1219913-2019-00152, mdr 1219913-2019-00152 supplemental 1, mdr 1219913-2019-00152 supplemental 2, mdr 1219913-2019-00152 supplemental 3 and mdr 1219913-2019-00152 supplemental 4 were filed for the sample tested on july 18, 2019 on advia centaur xp 3.

• Brand Name: ADVIA CENTAUR XP ANTI-HBS2 (AHBS2) ASSAY
• Type of Device: AHBS2 IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 8865285
• MDR Text Key: 214794516
• Report Number: 1219913-2019-00148
• 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,Followup,Followup,Followup
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2020
• Device Model Number: N/A
• Device Catalogue Number: 10286268
• Device Lot Number: 104
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 34 YR