MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP FT3 ASSAY; FT3 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	09/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause for the false low advia centaur xp ft3 results on readypack (b)(4) can be attributed to the laboratory workers removing the reagent readypack each morning from the system, and manually mixing it after it has been initially loaded and pierced.The liquid (lite reagent and solid phase) spills and mixes causing solid phase contamination into the lite reagent.Siemens has performed studies, and observed solid phase contamination into the lite reagent can cause quality control and patient results to be lower.The instruction for use (ifu) under the preparing reagents states the following: "all reagents are liquid and ready to use." "caution mix all primary reagent packs by hand before loading them onto the system.Visually inspect the bottom of the reagent pack to ensure that all particles are dispersed and resuspended.For detailed information about preparing the reagents for use, refer to the system operating instructions." the instruction for use (ifu) under the interpretation of results 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 specification.No further device evaluation is required.
Event or Problem Description
False low advia centaur xp ft3 results were obtained by the customer on a reagent readypack and considered discordant when compared to higher results on another reagent readypack that has acceptable quality control results.There are no reports that treatment was altered or prescribed or adverse health consequences due to the low centaur xp ft3 results.

• Brand Name: ADVIA CENTAUR XP FT3 ASSAY
• Common Device Name: FT3 IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 7328423
• Report Number: 1219913-2018-00101
• Device Sequence Number: 1630526
• Product Code: CDP
• UDI-Device Identifier: 00630414207537
• UDI-Public: 00630414207537
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K991692
• 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
• Report Date (Section B): 03/09/2018

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: 06/29/2018
• Device Model Number: N/A
• Device Catalogue Number: 10310318
• Device Lot Number: 006221
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2028
• Initial Report FDA Received Date: 03/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1