MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP ANTI-HBS2 (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 02/08/2019

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) was sent to the customer site for system inspection.The cse replaced the wash separation manifold and tested the system.Siemens healthcare diagnostics is investigating.Mdr 1219913-2019-00027 was filed for the same event (different patient).

Event Description

Reactive advia centaur xp anti-hbs2 (ahbs2) results were obtained for a patient sample.The patient sample was tested on an alternate method and the result was negative.A corrected report was issued.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the anti-hbs2 results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2019-00031 on (b)(6) 2019.(b)(6) 2019 additional information: the cse replaced the wash separation manifold and tested the system.A possible cause of the elevated results for this direct assay are poor aspiration of waste or system contamination.For this assay the wash separation manifold is responsible for the aspiration of unbound waste material at aspirate positions 1, 2, 3, and 4 and dispensing of wash 1 at dispense ports 1, wash displacement (wd), and 3 during the washing process.Damage to the wash separation manifold could cause elevated results.However, this could not be confirmed as the cause of the false positive results.The instrument is performing within specifications.No further evaluation of the device is required.Mdr 1219913-2019-00027 supplemental report 1 was filed for the same event (different patient).

• Brand Name: ADVIA CENTAUR XP ANTI-HBS2 (AHBS2)
• Type of Device: AHBS2 IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 8384261
• MDR Text Key: 137719809
• Report Number: 1219913-2019-00031
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 00630414561790
• UDI-Public: 00630414561790
• 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: 03/15/2019

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: 10286268
• Device Lot Number: 93209102
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/11/2019
• Initial Date FDA Received: 03/02/2019
• Supplement Dates Manufacturer Received: 03/06/2019
• Supplement Dates FDA Received: 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 29 YR