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

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 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

The cause for the false negative advia centaur xp anti-tg (atg) result is unknown.The customer's quality control (qc) was within acceptable ranges.Siemens is investigating.The instruction for use (ifu) under the interpretation of results section states the following: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings.".

Event Description

A false negative advia centaur xp anti-tg (atg) result was obtained on a patient sample when tested with reagent lot 085298.The low atg result was considered discordant compared to an initial positive result with reagent lot 085295.The initial positive result was in agreement with the clinical picture of the patient, and the result reported to the physician.Patient treatment was not altered or prescribed or adverse health consequences due to the discordant advia centaur xp atg result.

Manufacturer Narrative

Siemens filed mdr on 06/20/2018 for a false negative advia centaur xp anti-tg (atg) patient result when tested with reagent lot 085298.06/27/2018 - additional information: the cause for the false negative advia centaur xp anti-tg (atg) patient result when tested with reagent lot 085298 is unknown, and may be attributed to sample preparation and sample handling.The patient sample is not available for further investigation.No conclusion can be drawn.The instruction for use (ifu) under the interpretation of results section states the following: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." the instrument is performing within specifications.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR XP ANTI-TG (ATG) ASSAY
• Type of Device: ANTI-TG (ATG) IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 7620572
• MDR Text Key: 112459677
• Report Number: 1219913-2018-00176
• Device Sequence Number: 1
• Product Code: JZO
• UDI-Device Identifier: 00630414579221
• UDI-Public: 00630414579221
• Combination Product (y/n): N
• PMA/PMN Number: K012777
• 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: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2018
• Device Model Number: N/A
• Device Catalogue Number: 10492399
• Device Lot Number: 085298
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR