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

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/23/2018

Event Type  malfunction  

Manufacturer Narrative

The cause for the (b)(6) advia centaur xp anti-hbs2 (ahbs2) patient result and out of range quality control (qc) results with the new reagent lot (119096) is unknown.There has been no similar issue with other patient samples during this occurrence.Repeat testing with (b)(6) on (b)(6) 2018 showed consistent result to lot 119090 as a (b)(6) result ((b)(6)) was obtained with lot 119096.As part of troubleshooting testing, anti-hbs2 master curve material (mcm, lot 71943) showed acceptable results between lot 119096 and lot 119102.Only mcm level 5 was evaluated with reagent lot 119090 due to sample availability during testing.Additional testing with patient samples showed similar results between lot 119090 and lot 119096.The customer accepted lot 119096 as per laboratory protocol, and adjusted qc ranges accordingly.Qc results were similar to bio-rad peer data for virotrol ii qc.A review of in-house data showed the performance of reagent lot 119096 met all release criteria.Master curve material (mcm) results (miu/ml):(b)(6).Additional patient samples run on reagent lot 119096 had similar results to reagent lot 119090 (actual results not provided).The instrument is performing within specification.No further evaluation of the device is required.

Event Description

A (b)(6) advia centaur xp anti-hbs2 (ahbs2) result was obtained by the customer when performing a reagent lot (119090) to a new reagent lot (119096) validation study.The patient result with reagent lot 119090 is considered to be correct as quality control (qc) was in range, and the quality control (qc) results were out of range high for the new reagent lot (119096).There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant advia centaur xp anti-hbs2 (ahbs2) validation result.

• Brand Name: ADVIA CENTAUR XP ANTI-HBS2 (AHBS2) ASSAY
• 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: stephen perry ; 333 coney street; east walpole, MA 02032 ; 5086604163
• MDR Report Key: 8176503
• MDR Text Key: 131905003
• Report Number: 1219913-2018-00300
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 00630414561790
• UDI-Public: 00630414561790
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/18/2018

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: 05/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 10698706
• Device Lot Number: 119096
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2018
• Initial Date FDA Received: 12/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1