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 03/04/2019

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) was sent to the customer site for system inspection.The fse performed the following: check wash manifold.Check wash1 and water volume on distribution port 1,2,3,4, work as specifications.Check wash valves, correct.Check aspiration probes 1,2,3,4; correct.Check vacuum , work as specified.Reagent probes r1 & r2 work properly.Note: an electric connector of the valve manager board was not correctly plugged, corrected.The cause for the discordant (b)(6) results is unknown.Siemens healthcare diagnostics is investigating.Mdr 1219913-2019-00084 (sid (b)(6)), mdr 1219913-2019-00085 (sid (b)(6)), mdr 1219913-2019-00086 (sid (b)(6)), mdr 1219913-2019-00088 (sid (b)(6)), mdr 1219913-2019-00089 (sid (b)(6), lot 092), and mdr 1219913-2019-00090 (sid (b)(6), lot 102) were filed for the same event.

Event Description

(b)(6) advia centaur xp anti-hbs2 (ahbs2) results were obtained for a patient sample.The sample was repeated at a later date.The result was (b)(6).A corrected report was issued.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the anti-hbs2 results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2019-00087 on may 22, 2019.09/09/2019 additional information: the customer is using ahbs2 lots: 104 and 106.The number of false positives seemed to decrease.The customer applied the recommendations about reverse the tube at the blood collection time, and a more important time for coagulation for the pregnant women.Siemens continues to investigate.Mdr 1219913-2019-00084 supplemental report 1 (sid: (b)(6), mdr 1219913-2019-00085 supplemental report 1 (sid: (b)(6), mdr 1219913-2019-00086 supplemental report 1 (sid: (b)(6), mdr 1219913-2019-00088 supplemental report 1 (sid: (b)(6), mdr 1219913-2019-00089 supplemental report 1 (sid: (b)(6), lot: 092), and mdr 1219913-2019-00090 supplemental report 1 (sid: (b)(6), lot: 102) were filed for the same event.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2019-00087 on may 22, 2019.Siemens filed the mdr 1219913-2019-00087 supplemental report 1 on october 3, 2019.May 13, 2020 additional information: siemens performed testing on 203 nonreactive patient samples originating from us (157 samples), europe (26 samples), and asia (20 samples) on the advia centaur anti-hbs2 reagent lots 102 (complaint lot) and 106 (reference lot).With the advia centaur anti-hbs2 reagent lot 102, 8 were in the retest zone, 2 were reactive, and 193 were nonreactive.Upon retest, 4 samples resolved nonreactive and 1 sample resolved reactive on lot 102.Sufficient volume was not available to retest 3 of the patient samples initially in the retest zone with lot 102; however, 1 sample read < 10 miu/ml (9.13) and is considered nonreactive while 2 samples read >10 miu/ml (10.9 and 11.7) and are considered reactive.The resolved relative specificity for this study is shown below: reagent lot 102, resolved relative specificity = (b)(4).With advia centaur anti-hbs2 reagent lot 106, 2 were in the retest zone, 0 were reactive, and 201 were nonreactive.Sufficient volume was not available to retest the 2 patient samples initially in the retest zone with lot 106; however, both samples read < 10 miu/ml (8.74 and 9.06) and are considered nonreactive.The resolved relative specificity for this study is shown below: reagent lot 106, resolved relative specificity = (b)(4).The proportion confidence intervals calculated for reagent lots 102 and 106 overlap with each other and with the instructions for use (ifu) claim.Ifu claim (ifu (b)(4)).Resolved relative specificity = (b)(4).Siemens tested 112 reactive patient samples originating from us (43 samples), europe (49 samples), and asia (20 samples) on the advia centaur anti-hbs2 reagent lots 102 (complaint lot) and 106 (reference lot).With advia centaur anti-hbs2 reagent lot 102, 2 were in the retest zone, 110 were reactive, and 0 were nonreactive.Sufficient volume was not available to retest the 2 patient samples initially in the retest zone with lot 102; however, both samples read > 10 miu/ml (11.7 and 11.1) and are considered reactive.The resolved relative sensitivity for this study is shown below: reagent lot 102, resolved relative sensitivity = (b)(4).Siemens performed testing with the advia centaur anti-hbs2 reagent lot 106, 3 were in the retest zone, 109 were reactive, and 0 were nonreactive.Upon retest, 2 samples resolved reactive on lot 106.Sufficient volume was not available to retest 1 of the patient samples initially in the retest zone with lot 106; however, the sample read > 10 miu/ml (11.1) and is considered reactive.The resolved relative sensitivity for this study is shown below: reagent lot 106, resolved relative sensitivity = (b)(4).The proportion confidence intervals calculated for reagent lots 102 and 106 overlap with each other and with the instructions for use (ifu) claim.Ifu claim (ifu (b)(4)), resolved relative sensitivity = (b)(4).Based on statistical analysis there is not enough information to state that there is a statistical difference between complaint lot 102 and reference lot 106, or between either lot and the ahbs2 ifu claims for clinical specificity and sensitivity.The customer had 8 samples that varied between recovering reactive (10 - 36 miu/ml) and nonreactive (3 - 9 miu/ml) when tested with advia centaur xp anti-hbs2 (ahbs2) lots 092 and 102.When they tested 5 samples in replicates of 10 some results were reactive and some were nonreactive for the same sample when tested with advia centaur xp anti-hbs2 (ahbs2) lots 092 and 102.The customer was not centrifuging samples after they were thawed.The specimen collection and handling section of the advia centaur xp/xpt anti-hbs2 instructions for use (ifu) indicates after thawing samples should be thoroughly mix and centrifuged before using.Particulate matter caused by thawing frozen samples could explain the intermittent reactive results seen by the customer.Also, the vacutainer blood draw tubes were not being mixed (inverted) as per becton dickinson (bd) recommendations.When the customer applied recommendations about inverting the tube at the blood collection time and adjusting the coagulation time for the pregnant women they saw fewer false positives with lots 104 and 106.Siemens sourced patients samples from asia, europe, and the united states and while some samples did perform similar to the customer's samples with the advia centaur xp ahbs2 assay, the number of samples does not indicate the advia centaur xp ahbs2 assay is failing to meet the specificity claim in the instructions for use (ifu).A review of smart remote services (srs) field data from europe by siemens for advia centaur xp lots showed lot 102 had a similar distribution of nonreactive/reactive results to other lots.The clinical sensitivity and specificity section of the advia centaur xp/xpt anti-hbs2 ifu lists the 95% confidence interval (ci) for resolved relative specificity as (b)(4) so a certain number of false positive results can be expected for this assay.A review of internal and field data indicates advia centaur xp lots 092 and 102 are performing as intended.The cause of the intermittent reactive results seen by the customer when using with advia centaur xp ahbs2 lots 092 and 102 could not be determined but siemens cannot rule out pre-analytical factors, a sample issue, or normal assay performance.Siemens has requested additional information in order to further evaluate the issue.Mdr 1219913-2019-00084 supplemental report 2 (sid (b)(6)), mdr 1219913-2019-00085 supplemental report 2 (sid (b)(6), sid (b)(6)), mdr 1219913-2019-00086 supplemental report 2 (sid 112076), mdr 1219913-2019-00088 supplemental report 2 (sid 110167), mdr 1219913-2019-00089 supplemental report 2 (sid (b)(6), lot 092), and mdr 1219913-2019-00090 supplemental report 2 (sid 116024, lot 102) were filed for the same event.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2019-00087 on may 22, 2019.Siemens filed the mdr 1219913-2019-00087 supplemental report 1 on october 3, 2019.Siemens filed the mdr 1219913-2019-00087 supplemental report 2 on june 05, 2020.June 18, 2020 additional information: the customer had 8 samples that varied between recovering reactive (10 - 36 miu/ml) and nonreactive (3 - 9 miu/ml) when tested with advia centaur xp anti-hbs2 (ahbs2) lots 092 and 102.When the customer tested 5 samples in replicates of 10, some results were reactive and some were nonreactive for the same sample when tested with advia centaur xp anti-hbs2 (ahbs2) lots 092 and 102.The customer was not centrifuging samples after they were thawed.The specimen collection and handling section of the advia centaur xp/xpt anti-hbs2 instructions for use (ifu) indicates after thawing samples should be thoroughly mix and centrifuged before using.Particulate matter caused by thawing frozen samples could explain the intermittent reactive results seen by the customer.Also, the vacutainer blood draw tubes were not being mixed (inverted) as per becton dickinson (bd) recommendations.When the customer applied recommendations about inverting the tube at the blood collection time and adjusting the coagulation time for the pregnant women, they saw fewer false positives with lots 104 and 106.Siemens sourced patients samples from asia, europe, and the united states and while some samples did perform similar to the customer's samples with the advia centaur xp ahbs2 assay, the number of samples does not indicate the advia centaur xp ahbs2 assay is failing to meet the specificity claim in the instructions for use (ifu).A review of smart remote services (srs) field data from europe by siemens for advia centaur xp lots showed lot 102 had a similar distribution of nonreactive/reactive results to other lots.The clinical sensitivity and specificity section of the advia centaur xp/xpt anti-hbs2 ifu 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.A review of internal and field data indicates advia centaur xp lots 092 and 102 are performing as intended.The cause of the intermittent reactive results seen by the customer when using with advia centaur xp ahbs2 lots 092 and 102 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 instrument is performing within specifications.No further evaluation of the device is required.Section h6, the device, method, results and conclusion codes were updated to reflect the additional information.Mdr 1219913-2019-00084 supplemental report 3 (sid (b)(6)), mdr 1219913-2019-00085 supplemental report 3 (sid (b)(6), sid (b)(6)), mdr 1219913-2019-00086 supplemental report 3 (sid (b)(6)), mdr 1219913-2019-00088 supplemental report 3 (sid (b)(6)), mdr 1219913-2019-00089 supplemental report 3 (sid (b)(6), lot 092), and mdr 1219913-2019-00090 supplemental report 3 (sid (b)(6), lot 102) were filed for the same event.

• 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 5097
• MDR Report Key: 8632233
• MDR Text Key: 145792513
• Report Number: 1219913-2019-00087
• 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
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2020
• Device Model Number: N/A
• Device Catalogue Number: 10286268
• Device Lot Number: 092
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1