MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2); AHBS2 IMMUNOASSAY

Catalog Number 10995453

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

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

Event Type  malfunction  

Manufacturer Narrative

Siemens is investigating.Additional information has been requested of the customer by siemens.The interpretation of results section of the instructions for use sates, "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." the limitations section of the instructions for use states, "results from patients taking biotin supplements or receiving high-dose biotin therapy should be interpreted with caution due to possible interference with this test." the following mdrs were also filed for this issue: mdr 1219913-2019-00141 (for patient sample (b)(6) initial result).Mdr 1219913-2019-00142 (for patient sample (b)(6) repeat result).Mdr 1219913-2019-00144 (for patient sample (b)(6) additional results).Mdr 1219913-2019-00145 (for patient sample (b)(6) additional results).

Event Description

A customer obtained discordant false (b)(6) results on 2 patient samples with atellica im 1600 anti-hepatitis b surface antigen 2 (ahbs2) versus an alternate method.The results were reproduceable when the samples were retested.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant, falsely (b)(6) ahbs2 results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2019-2019-00143 on july 25, 2019.Correction from 08/12/2019: initial mdr 1219913-2019-2019-00143 contains results obtained on instrument designated as "atellica im00142", but the correct instrument designation is "atellica ih00142".Additional information from 08/12/2019: atellica im reagent kit lot used for testing: 25035111.Udi: (b)(4).Expiry date: 2020/09/26.For patient id: (b)(6).Gender: female.Age: 37 years (vaccination status unknown).Result reported to physician: 53 mui/ml.Additional testing results (method, unit of measure unknown): aghbs: (positive).Hbct: (positive).Hbcm: (negative).Hcv: (negative).For patient id: (b)(6).Gender: male.Age: 55 years (not vaccinated).Initial result test date: result reported to physician: <3.10 mui/ml.Additional testing results (method, unit of measure unknown): aghbs: (negative).Hbct: (negative).Hcv: (negative).Siemens continues to investigate the issue.The following mdr supplemental reports were also filed for this issue: mdr 1219913-2019-00141 supplemental report 1 (for patient sample (b)(6) initial result).Mdr 1219913-2019-00142 supplemental report 1 (for patient sample (b)(6) repeat result).Mdr 1219913-2019-00144 supplemental report 1 (for patient sample (b)(6) and (b)(6) additional results).Mdr 1219913-2019-00145 supplemental report 1 (for patient sample (b)(6) and (b)(6) additional results).

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2019-2019-00143 on (b)(6) 2019.And mdr 1219913-2019-2019-00143 supplemental report 1 on (b)(6) 2019.Additional information from 10/09/2019: the volume received for the samples sent to siemens was < 300ul and not sufficient to test.Siemens is currently evaluating ahbs2 lot to lot recovery and atellica im to advia centaur recovery.The clinical sensitivity and specificity section of the advia centaur xp/xpt anti-hbs2 instructions for use (b)(4), revision l, 2019-08) and the atellica im ahbs2 (b)(4), revision 03, 2019-04) lists the 95% confidence interval (ci) for resolved relative specificity as 98.34% - 99.88% and the 95% ci for resolved relative sensitivity as 98.30% - 100% so a certain number of false negative and false positive results can be expected for this assay.Additional information from 10/18/2019: the customer indicated that no further ahbs2 discrepant samples have been observed.The following mdr supplemental reports were also filed for this issue: mdr 1219913-2019-00141 (for patient sample (b)(6) initial result) mdr 1219913-2019-00142 (for patient sample(b)(6) repeat result) mdr 1219913-2019-00144 (for patient sample (b)(6) and (b)(6) additional results) mdr 1219913-2019-00145 (for patient sample (b)(6) and (b)(6) additional results).

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2019-00143 on july 25, 2019 and mdr 1219913-2019-00143 supplemental report 1 on august 30, 2019 and mdr 1219913-2019-00143 supplemental report 2 on october 30, 2019.Additional information 05/15/2020: investigation is complete.The samples were sent to siemens for evaluation but unfortunately the volume received was < 300ul and not sufficient to test.Different lots of reagents were used to make atellica im ahbs2 lot 111 than were used to make advia centaur ahbs2 lot 106 so the discrepant results are most likely a reagent lot to lot issue not a platform to platform issue.Siemens sourced patient samples from asia, europe, and the united states for further investigation and while some samples did perform similar to the customer's samples with the atellica im and advia centaur ahbs2 assay, the number of samples does not indicate the atellica im or advia centaur ahbs2 assay is failing to meet the specificity claim in the instructions for use (ifu).All of the positive samples sourced were reactive with all reagent lots tested so false negative samples were not observed.A review of smart remote services (srs) field data from europe showed atellica im ahbs2 lot 111 and advia centaur ahbs2 106 had similar distribution of nonreactive/reactive results compared to other lots.The clinical sensitivity and specificity section of the advia centaur xp/xpt anti-hbs2 ifu (10629819, revision l, 2019-08) and the atellica im ahbs2 ifu (10995277, revision 04, 2019-07) lists the 95% confidence interval (ci) for resolved relative specificity as 98.34% - 99.88% and the 95% ci for resolved relative sensitivity as 98.30% - 100%, so a certain number of false negative and false positive results can be expected for this assay.The 3 discrepant samples as observed by the customer do not indicate a product problem with atellica im ahbs2 lot 111 or advia centaur ahbs2 lot 106.A review of internal and field data indicates atellica im ahbs2 lot 111 and advia centaur ahbs2 lot 106 are performing as intended.The cause of the discrepant results seen by the customer when using atellica im ahbs2 lot 111 and advia centaur ahbs2 lot 106 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.No further investigation is 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.The following mdr supplemental 3 reports were also filed for this issue: mdr 1219913-2019-00141 (for patient sample (b)(6) initial result).Mdr 1219913-2019-00142 (for patient sample (b)(6) repeat result).Mdr 1219913-2019-00144 (for patient sample (b)(6) additional results).Mdr 1219913-2019-00145 (for patient sample (b)(6) additional results).

• Brand Name: ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2)
• Type of Device: AHBS2 IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 8829485
• MDR Text Key: 214791899
• Report Number: 1219913-2019-00143
• Device Sequence Number: 1
• Product Code: LOM
• 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: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10995453
• Device Lot Number: UNKNOWN
• 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