MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP ANTI-HBS2 (AHBS2); AHBS2 IMMUNOASSAY

Model Number	N/A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is investigating.
Event or Problem Description
A customer obtained discordant positive advia centaur xpt anti-hbs2 (ahbs2) patient results compared to the clinical picture, other clinical diagnostic test results as well as to the atellica im ahbs2 assay.There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant advia centaur xpt ahbs2 results.
Additional Manufacturer Narrative
Siemens filed mdr 1219913-2019-00270 reporting discordant positive advia centaur xpt anti-hbs2 (ahbs2) patient results (initial and repeat testing from one sample) compared to the clinical picture, other clinical diagnostic test results as well as to the atellica im ahbs2 assay.Additional information - january 3, 2020.Based on the information received, no product problem has been identified.Siemens cannot rule out preanalytical factors or a sample issue or normal assay performance for the false positive results seen by the customer.Siemens reviewed the calibration and control data provided and there is no evidence of a problem.The patient has hbv but the customer was not able to provide a list of medications/supplements the patient is taking.There is no sample that can be sent to siemens for evaluation.The clinical sensitivity and specificity section of the advia centaur xp/xpt anti-hbs2.Instructions for use (ifu) 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.This 1 false positive sample does not indicate a product problem with advia centaur xpt ahbs2 lot 116.The cause of the false positive results seen by the customer with this one sample when using advia centaur xpt ahbs2 lot 116 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.

• Brand Name: ADVIA CENTAUR XP ANTI-HBS2 (AHBS2)
• Common Device Name: AHBS2 IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 9472722
• Report Number: 1219913-2019-00270
• Device Sequence Number: 19481464
• Product Code: LOM
• UDI-Device Identifier: 00630414561790
• UDI-Public: 00630414561790
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• PMA/510(K) Number: P100039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2020
• Device Model Number: N/A
• Device Catalogue Number: 10286268
• Device Lot Number: 64087116
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 01/03/2020
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 01/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1