MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) ASSAY; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

Model Number N/A

Device Problem High Test Results (2457)

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

Event Date 07/13/2023

Event Type  malfunction  

Event Description

The customer reports observation of a discordant elevated atellica im hepatitis b surface antigen antibodies 2 (ahbs2) for a 33-year-old male patient, when using reagent lot 161.The initial result was not reported to the physician(s).The patient also had a digestive tract disease.The sample was repeated on the same atellica im analyzer after centrifugation, and the result was comparable.The same sample was repeated on advia centaur xp before and after centrifugation, and lower negative result was obtained.There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant ahbs2 result.

Manufacturer Narrative

An outside the united states customer reports observation of a discordant elevated atellica im hepatitis b surface antigen antibodies (ahbs2) for a 33-year-old male patient, when using reagent lot 161.The initial result was not reported to the physician(s).The patient also had a digestive tract disease.The sample was repeated on the same atellica im analyzer after centrifugation, and the result was comparable.The same sample was repeated on advia centaur xp before and after centrifugation, and lower negative result was obtained.The interpretation of results section of the atellica im hepatitis b surface antigen antibodies (ahbs2) instructions for use states: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens continues to investigate.

Manufacturer Narrative

Initial mdr 1219913-2023-00141 was filed on jul 26, 2023.Additional information ¿ aug 15, 2023: a customer from outside the united states reported the initial issue as atellica im hepatitis b surface antibody 2 (ahbs2) false positive result on a single patient sample.Patient sample was later tested on advia centaur ahbs2 and produced a negative (nonreactive) result.Siemens investigation included an assessment of reagent, instrument, and sample data.Reagent issues were ruled out based on a review of quality control (qc), which showed recovery within acceptable ranges, and no issues were reported with any other patient samples.Additional hepatitis infection disease tests were performed on the patient sample and also came back as reactive, indicating an issue with the patient sample and possible nonspecific interference within the patient sample.Based on the available information, the cause of the discordant result is consistent with a sample specific interferent.The assay is performing as expected and within specifications.The results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings.Return of the patient sample for further investigation is not possible due to china regulations.The customer is currently operational.The issue was resolved with routine troubleshooting.In section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) ASSAY
• Type of Device: TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; 333 coney street; east walpole MA 02032
• Manufacturer Contact: louise mclaughlin ; 333 coney st.; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 17396956
• MDR Text Key: 320030282
• Report Number: 1219913-2023-00141
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 00630414597836
• UDI-Public: 00630414597836
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 08/22/2023

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 Model Number: N/A
• Device Catalogue Number: 10995453
• Device Lot Number: 161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2023
• Initial Date FDA Received: 07/26/2023
• Supplement Dates Manufacturer Received: 08/15/2023
• Supplement Dates FDA Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2022
• 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 Age: 33 YR
• Patient Sex: Male