MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2); 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 02/13/2019

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant (b)(6) atellica im 1600 ahbs2 result is unknown.Siemens is investigating this issue.The ifu states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." mdr 1219913-2019-00074 (for patient sample id (b)(6)) was filed for the same issue.

Event Description

Discordant (b)(6) atellica im 1600 anti-hepatitis b surface antigen 2 (ahbs2) results were obtained with two reagent lots on different samples of a single patient on two different days.On (b)(6) 2019, the atellica im ahbs2 sample (sid: (b)(6)) result was (b)(6).On (b)(6) 2019, the atellica im ahbs2 sample (sid: (b)(6)) result was (b)(6).The sample was run on an alternate method for ahbs and the result was not (b)(6).Customer believes the alternate method result to be correct because it matches the patient's clinical picture.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant, (b)(6) ahbs2 results.

Manufacturer Narrative

Siemens filed the initial mdr (for sid (b)(6)) on may 02, 2019.Additional information 05/29/2019: the customer has indicated that they had another patient sample some months ago that was reactive (~67 miu/ml) with the atelica im ahbs2 assay but nonreactive when analyzed on an alternate method.The sample was not repeated on atellica im by the customer and no more samples of the same patient have been analyzed.No other information was provided regarding this patient.Additional testing was performed by siemens technical support lab (tsl) on the customer returned patient sample.Tsl tested the sample with atellica im ahbs2 lot 117 and it recovered reactive (629 miu/ml) so the issue with the sample is not specific to the lots used by the customer or to the customer's instrument.The sample was also tested with the immulite 2000 anti-hbs assay and recovered nonreactive (3.19 miu/ml) which confirms the nonreactive result of the alternate anti-hbs method.Testing by the tsl was not able to identify an interferent in the patient's sample that is elevating atellica im ahbs2 result.The clinical sensitivity and specificity section of the atellica im ahbs2 instructions for use (ifu) (10995277 revision 02, 2017-12) lists the 95% confidence interval (ci) for resolved relative specificity as 98.34% - 99.88%.Based on smart remote services (srs) data the customer has tested >881 nonreactive samples with atellica im ahbs2 lot 109 and >432 nonreactive samples with atellica im ahbs2 lot 111.Therefore, their specificity, assuming two false positive samples, with lot 109 is >99.8% and their specificity with lot 111 is >99.5%.The cause of the elevated results with these samples when using atellica im ahbs2 lots 109 and 111 could not be determined but siemens cannot rule out normal assay performance, pre-analytical factors, or a sample issue.Based on the investigation, no product problem was identified.No further evaluation of the device is required.Mdr 1219913-2019-00074 (for patient sample id (b)(6)) was filed for the same issue.

• 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: 8575598
• MDR Text Key: 206357512
• Report Number: 1219913-2019-00073
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 00630414597836
• UDI-Public: 00630414597836
• 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
• Report Date: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: N/A
• Device Catalogue Number: 10995453
• Device Lot Number: 119109
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/09/2019
• Initial Date FDA Received: 05/02/2019
• Supplement Dates Manufacturer Received: 05/29/2019
• Supplement Dates FDA Received: 06/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1