MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT TSH3-ULTRA (TSH3-UL); TSH3-UL 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	10/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagents were clumped on isolated reagent packs.The customer received (b)(4) boxes of this lot, all at one time, and started using it on (b)(6) 2017.The customer changed their storage method from a revolving shelf refrigerator to a walk in refrigerator on (b)(6) 2017.The customer resolved the issue by repeating the patient samples on another kit where the reagents were homogenous and the quality control was in range.The most likely cause of the discordant results is clumped solid on isolated readypacks.The customer is now checking all reagent readypacks for clumps before running and requires no further assistance from siemens.The instrument is performing within specifications.No further evaluation of the device is required.The ifu states in the interpretation of results: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." the ifu states in the preparing the system section: "ensure that the system has sufficient primary and ancillary reagent packs.For detailed information about preparing the system, refer to the system operating instructions.Load the readypack reagent packs in the primary reagent area using the arrows as a placement guide.The system automatically mixes the primary reagent packs to maintain homogeneous suspension of the reagents.For detailed information about loading reagents, refer to the system operating instructions.If dilution of a sample is required, load advia centaur multi-diluent 15 in the ancillary reagent area." mdr 1219913-2017-00229 was filed for the same event.
Event or Problem Description
Discordant low advia centaur xpt tsh3-ultra (tsh3-ul) results were obtained for samples from two patients.The results were reported to the physician and questioned.The patient samples were repeated and the expected results were obtained.A corrected report was issued.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant tsh3-ultra result.

• Brand Name: ADVIA CENTAUR XPT TSH3-ULTRA (TSH3-UL)
• Common Device Name: TSH3-UL IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 7067597
• Report Number: 1219913-2017-00226
• Device Sequence Number: 10784660
• Product Code: JLW
• UDI-Device Identifier: 00630414535654
• UDI-Public: 00630414535654
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K150403
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/29/2017

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: 03/10/2018
• Device Model Number: N/A
• Device Catalogue Number: 10282378
• Device Lot Number: 301
• 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: 11/06/2017
• Initial Report FDA Received Date: 11/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1