MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP HAV TOTAL (AHAVT) ASSAY; HEPATITIS A VIRUS (ANTI-HAV) ASSAY

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 08/01/2016

Event Type  malfunction  

Manufacturer Narrative

The cause for the (b)(6) patient results compared to an alternate method is unknown.The customer's quality control results were acceptable at the time of the testing.Siemens is investigating this incident and has requested the patient samples for investigation.Advia centaur (b)(4) reagent lot 073182; date of manufacture 06-30-2016; expiration date 06-30-2017; udi - to be provided.

Event Description

Customer reported that they are observing (b)(6) results with the advia centaur (b)(4) assay.The results do not agree with an alternate method.There are no reports that treatment was altered or prescribed based on the advia centaur xp (b)(6) results.

Manufacturer Narrative

Siemens filed mdr 1219913-2017-00015 on february 9, 2017 reporting a number of (b)(6) samples with the advia centaur xp hav total (ahavt) assay that did not agree with an alternate method.March 7, 2017 additional information: siemens evaluated the standardization of the advia centaur xp ahavt in comparison to who standardization and found that who standards and master curve standards are close to target.The 2pt calibration results are biased high compared to the who standards and master curve standards.Siemens also identified that internal controls are running outside of internal ranges.Siemens continues to investigate the issue.

Manufacturer Narrative

Siemens filed mdr 1219913-2017-00015 on february 9, 2017 reporting a number of (b)(6) samples with the advia centaur xp (b)(6) assay that did not agree with an alternate method.Mdr 1219913-2017-00015 supplemental 1, was filed on march 7, 2017 with additional information regarding the investigation.February 14, 2018 - additional information: siemens' investigation showed that all specifications are met; however a two-point calibration bias to the internal master curve and a higher bias to who material than what has been historically observed was seen with reagent lot 104077 and the sister lot 073182 which expired june 30, 2017.These biases could manifest as an increase in the number of positive sample results.Additionally, siemens reviewed siemens real time solutions (srs) data.This data shows a higher percentage of patients above the assay cutoff with reagent lot 104077 (073182) than seen with other reagent lots.The bias and the increase in the number of (b)(6) sample results are limited to this reagent lot(s).Siemens determined that the increase in the number of (b)(6) sample results was not due to a shipping or handling issue with the reagents as reagents returned to siemens performed similarly to siemens' retains.Root cause was not able to be determined prior to lot expiration and the issue does not appear to be a systemic (b)(6) total problem.Although root cause has not been identified and the product met all specifications, siemens is evaluating opportunities for process improvements to reduce the potential that future lots would exhibit similar performance.

• Brand Name: ADVIA CENTAUR XP HAV TOTAL (AHAVT) ASSAY
• Type of Device: HEPATITIS A VIRUS (ANTI-HAV) ASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; tarrytown NY 10591
• MDR Report Key: 6313976
• MDR Text Key: 67388015
• Report Number: 1219913-2017-00015
• Device Sequence Number: 1
• Product Code: LOL
• Combination Product (y/n): N
• PMA/PMN Number: P040017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2017
• Device Model Number: N/A
• Device Catalogue Number: 10322676
• Device Lot Number: 073180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1