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	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause for the false negative advia centaur xp anti-tg (atg) result is unknown.Siemens healthcare diagnostics 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 085304.The negative atg result was considered discordant compared to an initial positive result with reagent lot 085298.The initial positive result was reported to the physician.Patient treatment was not prescribed or altered.There was no report of adverse health consequences as a result of these discordant atg results.
Additional Manufacturer Narrative
08/10/2018 additional information: the patient sample was tested as part of a lot to lot method comparison.The customer application specialist (cas) went to the customer site.The cas confirmed the discordant result and that recalibrations cannot resolve this issue.The patient sample could not be returned to siemens for internal testing due to china customs issues.Without having the samples to test, siemens can't confirm the customer's observation or determine a possible cause.The most likely cause is sample specific issues such as sample preparation or sample storage.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: 7739055
• Report Number: 1219913-2018-00201
• Device Sequence Number: 1040335
• Product Code: JZO
• UDI-Device Identifier: 00630414579214
• UDI-Public: 00630414579214
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2018

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: 01/12/2019
• Device Model Number: N/A
• Device Catalogue Number: 10492398
• Device Lot Number: 085304
• Initial Date Received by Manufacturer: 07/28/2018
• Supplement Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 08/01/2018
• Supplement Report FDA Received Date: 08/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 27 YR