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

Model Number N/A

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/13/2023

Event Type  malfunction  

Manufacturer Narrative

A customer from outside the united states reported observation of positive atellica im anti-hepatitis b surface antigen 2 (ahbs2) results for one patient which were discordant relative to alternate-method testing.On (b)(6) 2023, a positive ahbs2 result of 27 miu/ml was obtained for a female chronic hepatitis patient who has been undergoing antiviral treatment.This initial result was not reported to the physician.Additional testing was performed on this sample, using alternate methods at an external lab: hbs antibodies: <2 (negative) - this result was communicated to the doctor, as consistent with clinical expectation.Hbs antigens: positive.On (b)(6) 2023, a retained sample (drawn on (b)(6) 2023) from the same patient was subjected to additional testing: atellica ahbs2: 40.94 miu/ml (positive).Pcr viremia: negative.It is noted that the same patient had tested negative for ahbs2 in 2015, and that the patient had been hbct and hbsii positive since 2013.The atellica im tnih instructions for use (ifu) states the following, under limitations: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings".Siemens is investigating.Note: the discordant observation of (b)(6) 2023 is reported in mdr 1219913-2023-00040.

Event Description

The customer reported observation of a positive atellica im anti-hepatitis b surface antigen 2 (ahbs2) result for one patient which was discordant relative to alternate-method testing.The negative (alternate-method) result was accepted as consistent with patient clinical indications.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with the observed discordance.

Manufacturer Narrative

Mdr 1219913-2023-00039 was initially submitted on 2023-02-27.Update, 2023-04-27: siemens has concluded the investigation.A customer from outside the united states reported observation of positive atellica im anti-hepatitis b surface antigen 2 (ahbs2) results for one patient which were discordant relative to alternate-method testing.Siemens requested the affected sample for additional testing, but there was insufficient volume available.It was noted that the patient has a history of chronic hepatitis with ongoing antiviral treatments.Quality control (qc) performance was reviewed, with no issues noted.Based on the observed replication of elevated results, siemens cannot rule out pre-analytical factors or a sample-specific interferent as the cause of the reactive testing.The clinical sensitivity and specificity section of the atellica im anti-hepatitis b surface antigen 2 (ahbs2) instructions for use (ifu) states 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.The assay is performing as expected and within specifications.Results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings.Based on the investigation, no product problem was identified.The customer is operational and requires no further support.Notes: 1) in section h6, the codes for investigation findings and investigation conclusion have been updated.2) mdr 1219913-2023-00040 supplemental 1 has been filed in association with the related observation of 2023-02-16.

• Brand Name: ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2)
• Type of Device: AHBS IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; east walpole MA 02032
• Manufacturer Contact: barry ; 333 coney street; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 16448552
• MDR Text Key: 310431126
• Report Number: 1219913-2023-00039
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 00630414597836
• UDI-Public: 00630414597836
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P100039-S005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/26/2024
• Device Model Number: N/A
• Device Catalogue Number: 10995453
• Device Lot Number: 155
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female