MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP HBSAGII (HBSII); HEPATITI B SURFACE ANTIGAN IMMUNOASSAY

Model Number N/A

Device Problems False Negative Result (1225); No Apparent Adverse Event (3189)

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

Event Date 02/25/2020

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics is investigating.There is no sample that can be sent to siemens for evaluation.The customer was not able to provide the patient's medical status or a list of medications/supplements the patient is taking.Siemens reviewed the calibration provided and there is no evidence of a problem.The customer did not provide control data.The percent agreement section of the advia centaur xp/xpt (b)(6) instructions for use (ifu) (10635153 revision h, 2019-07) lists the 95% confidence interval (ci) for negative agreement as 99.5% - 100% so a certain number of false positive results can be expected for this assay.The percent agreement section of the advia centaur xp/xpt (b)(6) instructions for use (ifu) (10635153 revision h, 2019-07) lists the 95% confidence interval (ci) for positive agreement as 92.0% - 98.8% so a certain number of false negative results can be expected for this assay.The discrepant samples from this one patient do not indicate a product problem with advia centaur xp (b)(6).A review of siemens' internal data indicates advia centaur xp (b)(6) lots 188 and 204 are performing as intended.Based on the investigation to date, the cause of the discrepant results seen by the customer with samples from this one patient when using advia centaur xp (b)(6) could not be determined but siemens cannot rule out pre-analytical factors, a sample issue, or normal assay performance; no product problem was identified to date.Siemens has requested instrument service information.The advia centaur xp/xpt (b)(6) instructions for use (ifu) under the limitation section states the following: "for diagnostics purposes, the advia centaur (b)(6) test results should always be assessed in conjunction with the patient's medical history, clinical examination, and other findings." "it is recognized that the current methods for the detection of (b)(6) surface antigen may not detect all potential infected individuals.A nonreactive test result does not exclude the possibility of exposure to or infection with (b)(6).A nonreactive test result in individuals with prior exposure to hepatitis b may be due to antigen levels below the detection limit of this assay or lack of antigen reactivity to the antibodies in this assay." mdr 1219913-2020-00096 was filed for the (b)(6) 2020 discordant (b)(6) results.Mdr 1219913-2020-00097 was filed for the (b)(6) 2020 discordant (b)(6) confirmatory result.

Event Description

A customer obtained false negative (non-reactive) results for one patient with advia centaur xp (b)(6) on 2 testing dates ((b)(6) 2020, (b)(6) 2020) compared to a previous positive (reactive) result.The customer indicates that the patient is considered positive for (b)(6).The false negative results from (b)(6) 2020 were not reported to physician.The false negative result from (b)(6) 2020 was reported to the physician who questioned the result.No additional information was provided for this testing date.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the false negative (b)(6) results.

Manufacturer Narrative

Siemens filed initial mdr 1219913-2020-00098 on 03/10/2020.Additional information from 05/05/2020: service was not dispatched for this notification as the issue was related to one sample and no system deficiencies were suspected.No further sample issues reported; no system issue identified.Additional information from 05/08/2020: the customer was not able to provide the patient's medical status or a list of medications/supplements the patient is taking.The sample was not able to be provided for futher investiggation.Siemens reviewed the calibration provided and there is no evidence of a problem.The customer did not provide control data.A review of internal data indicates advia centaur xp/xpt hbsii lots 188 and 204 are performing as intended.The cause of the discrepant results seen by the customer with samples from this one patient when using advia centaur xp hbsii lots 188 and 204 and the advia centaur xp hbsag conf assay could not be determined but siemens cannot rule out pre-analytical factors, a sample issue, or normal assay performance.Based on the investigation, no product problem was identified.The result code and conclusion code have been updated to reflect the addtional information.Reference section h6 of this report for the updated codes.Mdr 1219913-2020-00097 supplemental report 1 was filed for the 03/03/2020 discordant hbsagii confirmatory result.Mdr 1219913-2020-00096 supplemental report 1 was filed for the 03/03/2020 discordant hbsagii results.

Manufacturer Narrative

Additional information from 06/15/2020: technical application service (tas) assistance was requested by customer for potential software issue because the sample initially resulted as reactive, but was automatically repeated by the system which resulted as non-reactive.The non-reactive result was sent to laboratory information system.Additional information from 06/16/2020: siemens investigation is complete.Siemens reviewed the instrument and event data including any actions performed by the customer service engineer (cse).No cse service was dispatched for this notification.The issue regarding the false positive patient result was found to be related to one patient sample.Siemens concluded that the cause of the discordant result was due to pre-analytical factors or a sample issue.No system hardware troubleshooting by field service was required, and the customer was satisfied.Regarding the issue present in the ticket of multiple replicates being run, the technical application service (tas) team member reviewed the system software settings for the advia centaur xpt and centralink.The tas observed that the final result rule, above check range, and above linearity settings were all selected, which cause the advia centaur xpt to run replicates.The tas removed the selections in order to stop repeats from being ordered from the advia centaur xpt instrument itself in addition to what was being ordered by centralink middleware.This allowed only centralink middleware to order replicates for reactive specimens.Post-tas support, the customer reports the system is handling hbsagii repeat testing correctly and there is no further concern.The system is now operational and fully functional.Based on the investigation, no assay or system or software problems were identified.No further investigation is required.Mdr 1219913-2020-00096 supplemental report 2 was filed for the (b)(6) 2020 discordant hbsagii result.Mdr 1219913-2020-00097 supplemental report 2 was filed for the (b)(6) 2020 discordant hbsagii confirmatory result.

• Brand Name: ADVIA CENTAUR XP HBSAGII (HBSII)
• Type of Device: HEPATITI B SURFACE ANTIGAN IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 9950990
• MDR Text Key: 228389732
• Report Number: 1219913-2020-00098
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 00630414578170
• UDI-Public: 00630414578170
• Combination Product (y/n): N
• PMA/PMN Number: P110041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2020
• Device Model Number: N/A
• Device Catalogue Number: 10492138
• Device Lot Number: 204
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1