MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XPT ANTI-HBS2 (AHBS2) ASSAY

Model Number N/A

Device Problem False Positive Result (1227)

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

Event Date 01/22/2023

Event Type  malfunction  

Manufacturer Narrative

A customer from outside the united states reported observation of a positive (reactive) advia centaur xpt anti-hbs2 (ahbs2) result for one patient which was discordant relative to repeat test results and clinical indications.Additional laboratory testing of the sample produced a negative result for hepatitis b antibody, which was accepted as correct.The assay's instructions for use (ifu) states the following, under limitations: "assay performance characteristics have not been established when the advia centaur anti-hbs2 assay is used in conjunction with other manufacturers' assay for specific hbv serological markers" siemens continues to investigate.

Event Description

The customer reports observation of a positive (reactive) advia centaur xpt anti-hbs2 (ahbs2) result for one patient which was discordant relative to repeat test results and clinical indications.The initial result was reported to physician(s), who did not question the result.The sample was repeated on the same atellica im analyzer, and the result was negative.There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant ahbs2 result.

Manufacturer Narrative

Initial mdr 1219913-2023-00024 was filed on feb 01, 2023 reporting a customer from outside the united states obtained a positive (reactive) advia centaur xpt anti-hbs2 (ahbs2) result for one patient which was discordant relative to repeat test results and clinical indications.Additional laboratory testing of the sample produced a negative result for hepatitis b antibody, which was accepted as correct.Additional information - feb 24, 2023.Siemens investigated the customer complaint for advia centaur xpt hepatitis b surface antibody (ahbs2) false positive result on a single patient sample.Two different sample existed for this patient where one sample resulted positive and the other resulted negative.Both samples were repeated on same advia centaur xpt, and both resulted negative.Sample were previously frozen, thawed and centrifuged before repeat.The customer was unable to provide any additional information regarding patient history or list of medications.The ahbs2 quality control (qc) testing on the day of the initial testing was within the range.Siemens performed a search in complaint database and found no related complaints from other customer sites.Related additional hepatitis testing was completed and was negative.Based on the result of the alternate patient sample, siemens cannot rule out pre-analytical factors or a sample specific interferent in the first sample as the cause of the initial reactive testing on (b)(6) 2023.The clinical sensitivity and specificity section of the advia centaur xp/xpt anti-hbs2 instructions for use (ifu) (10629819) 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.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 potential product issue is observed.The customer is operational.In section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ADVIA CENTAUR XPT ANTI-HBS2 (AHBS2) ASSAY
• Type of Device: ANTI-HBS2 (AHBS2) ASSAY
• 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: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 16277126
• MDR Text Key: 308547978
• Report Number: 1219913-2023-00024
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 00630414561790
• UDI-Public: 00630414561790
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P100039
• 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: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• 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: 10286268
• Device Lot Number: 158
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2022
• 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: 45 YR
• Patient Sex: Female