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

Model Number 10286268

Device Problems False Positive Result (1227); No Apparent Adverse Event (3189)

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

Event Date 09/04/2019

Event Type  malfunction  

Manufacturer Narrative

Siemens is investigating.Per the instructions for use, "specimens that contain biotin at a concentration of 1500 ng/ml demonstrate no significant effect on the assay.Biotin concentrations greater than this may lead to incorrect results for patient samples.Results from patients taking biotin supplements or receiving high-dose biotin therapy should be interpreted with caution due to possible interference with this test." mdr 1219913-2019-00178 was filed for the same event ((b)(6) 2019 result).

Event Description

A customer obtained discordant advia centaur xpt anti-hbs2 (ahbs2) patient results from one patient as compared to an alternate method.The patient sample was initially tested on (b)(6) 2019 with the advia centaur xpt ahbs2 assay.Other clinical diagnostic tests were also performed, including alternate test methods.A (b)(6) result was obtained with the advia centaur xpt ahbs2 assay, which was discordant compared to the result of the alternate ahbs method.The sample was retested on (b)(6) 2019 and a (b)(6) advia centaur xpt ahbs2 result was obtained again.The initial results were not reported to the physician.Results report was issued based on the alternate method ahbs results.There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant advia centaur xpt ahbs2 results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2019-00179 on september 26, 2019.Corrected information 10/29/2019: in section b5 (event) of the initial mdr 1219913-2019-00179, the sample retest date is stated as "09/24/2019", but should be 09/04/2019.Additional information 10/04/2019: the customer had a sample that was repeat reactive with advia centaur xpt anti-hbs2 (ahbs2) lot: 102.The sample is also hbsii reactive (1000 index), ahbcm nonreactive (0.16 index), havm nonreactive (0.02 s/co), and hcv nonreactive (0.03 index).When tested with an alternate method, the sample was anti-hbs nonreactive (4.78 iu/l), hbsag nonreactive (2902 s/co), and hbeag reactive (1828 s/co).Siemens does not have information indicating the medications being taken by the patient would interfere with the advia centaur xpt ahbs2 assay.There is insufficient volume of this sample that can be sent to siemens for evaluation.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 positive results can be expected for this assay.This 1 false positive result does not indicate a product problem with advia centaur xpt ahbs2 lot: 102.The cause of the false positive results seen by the customer with this one sample when using advia centaur xpt ahbs2 lot: 102 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 has been identified.Additional information 10/24/2019: the customer is providing siemens with an additional sample from the same patient as well as additional patient samples for further investigation of this issue.Mdr 1219913-2019-00178 supplemental report 1 was filed for the same event (09/03/2019 result).

Manufacturer Narrative

Siemens filed initial mdr 1219913-2019-00179 on september 26, 2019 and mdr 1219913-2019-00179 supplemental report 1 on october 29, 2019.Additional information 12/13/2019: while troubleshooting this incident with the customer, they are providing 2 additional samples to siemens for testing.Information regarding these samples is as follows: sample (b)(6): date (b)(6) 2019 male in for check up born in 1985.Siemens ahbs2 59.96 miu/ml roche ahbs <2.0 u/l.Siemens hbsii reactive (>1000 index) roche hbsag reactive (8010 index).Sample (b)(6): date (b)(6) 2019 female with premenopausal disorders born in 1970.Siemens ahbs2 178.56 miu/ml roche ahbs <2.0 u/l.Siemens hbsii reactive (>1000 index) roche hbsag not tested.Siemens continues to investigate.Mdr 1219913-2019-00178 supplemental report 2 was filed for the same event ((b)(6) 2019 result).

Manufacturer Narrative

Siemens filed initial mdr 1219913-2019-00179 on (b)(6) 2019 and mdr 1219913-2019-00179 supplemental report 1 on (b)(6) 2019 and mdr 1219913-2019-00179 supplemental report 2 on (b)(6) 2020.Additional information from (b)(6) 2020: a review of smart remote services (srs) field data by siemens for advia centaur xp ahbs2 showed reagent lot 102 had a similar distribution of nonreactive / reactive results compared to other lots.Siemens sourced patient samples from asia, europe, and the united states but we were not able to find more samples that perform similar to the customer's samples with the advia centaur xpt ahbs2 assay.Additional information from (b)(6) 2020: patient samples were not able to be sent to siemens from the customer site.No additional information was provided by the customer, who indicated that complaint can be closed.Additional information from (b)(6) 2020: investigation complete.The customer had a sample that was consistently reactive (286.87, 273.38 miu/ml) with advia centaur xpt anti-hbs2 (ahbs2) lot 102.The sample is also hbsii reactive (>1000 index), ahbcm nonreactive (0.16 index), havm nonreactive (0.02 s/co), and hcv nonreactive (0.03 index).When tested with the roche cobas the sample was anti-hbs nonreactive (4.78 iu/l), hbsag reactive (2902 s/co), and hbeag reactive (1828 s/co).The customer had two additional patient samples that were reactive with the advia centaur xpt ahbs2 assay but nonreactive with the roche cobas anti-hbs assay.Siemens does not have any information indicating medications provided would interfere with the advia centaur xpt ahbs2 assay.The samples were not sent to siemens for evaluation due to customs issues.Siemens sourced patient samples from asia, europe, and the united states but we were not able to find more samples that perform similar to these samples with the advia centaur xpt 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 positive results can be expected for this assay.A review of internal and field data indicates advia centaur xpt ahbs2 lot 102 is performing as intended.The cause of the discrepant results seen by the customer when using advia centaur xpt ahbs2 lot 102 could not be determined but siemens cannot rule out pre-analytical factors, sample issues, or normal assay performance.Based on the investigation, no product problem was identified.The customer is operational.No further investigation required.The device, method, result and conclusion codes have been updated to reflect the investigation results.Reference section h6 of this report for the updated codes.Mdr 1219913-2019-00178 supplemental report 2 was filed for the same event (09/03/2019 result).

• Brand Name: ADVIA CENTAUR XP ANTI-HBS2 (AHBS2)
• Type of Device: AHBS2 IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 9126445
• MDR Text Key: 214800246
• Report Number: 1219913-2019-00179
• 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: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2020
• Device Model Number: 10286268
• Device Catalogue Number: 10286268
• Device Lot Number: 83933102
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 17 YR