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 10/08/2016

Event Type  malfunction  

Manufacturer Narrative

The cause for the false reactive advia centaur xp hav total (ahavt) patient results compared to non-reactive repeat results is unknown.The customer's quality control results were acceptable at the time of the event.Siemens is investigating this incident and has requested the patient samples for investigation.

Event Description

Customer reported that they are observing a number of borderline reactive samples which are negative upon repeat testing with the advia centaur xp hav total (ahavt) assay.There are no reports that treatment was altered or prescribed or adverse health consequences due to the borderline reactive advia centaur xp ahavt results.

Manufacturer Narrative

Siemens filed mdr 1219913-2016-00216 on november 22, 2016 reporting a number of borderline (b)(6) samples which are (b)(6) upon repeat testing with the advia centaur xp (b)(4) assay.November 29, 2016 additional information: siemens requested additional information regarding the samples including the patient history and (b)(6) results.This information is not available for these samples.Siemens also requested the samples for additional testing but the samples are not available.These samples represent samples which are around the cutoff of the assay.Siemens continues to investigate the issue.

Manufacturer Narrative

Siemens filed mdr 1219913-2016-00216 on november 22, 2016 reporting a number of (b)(6) samples which are (b)(6) upon repeat testing with the advia centaur xp hav total (ahavt) assay.Mdr 1219913-2016-00216 was filed on december 20, 2016 providing an update that patients samples from the customer are not available.February 22, 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 1219913-2016-00216 on november 22, 2016 reporting a number of borderline (b)(6) samples which are (b)(6) upon repeat testing with the advia centaur xp (b)(6) assay.Mdr 1219913-2016-00216 supplemental 1 was filed on december 20, 2016 providing an update that patients samples from the customer are not available.Mdr 1219913-2016-00216 supplemental 2, was filed on february 22, 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 (b)(6) 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 positive 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: 6120836
• MDR Text Key: 60662043
• Report Number: 1219913-2016-00216
• 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,Followup
• Report Date: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 10322676
• Device Lot Number: 104182
• 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