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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/22/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: ANTI-TG (ATG) IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 7620572
• Report Number: 1219913-2018-00176
• Device Sequence Number: 2512492
• Product Code: JZO
• UDI-Device Identifier: 00630414579221
• UDI-Public: 00630414579221
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K012777
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2018

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 06/15/2018
• Supplement Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 06/20/2018
• Supplement Report FDA Received Date: 07/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR