MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM TSH3-ULTRA (TSH3-UL); TSH3-UL IMMUNOASSAY

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A discordant, falsely low atellica im tsh3-ultra (tsh3-ul) result obtained on a patient sample.The customer provided the original reagent readypack ((b)(4)), and two other reagent readypacks ((b)(4)) from reagent lot 352 for further investigation.Siemens performed internal testing on the returned customer readypacks and the findings determined degradation of the middle well (fitc) reagent.The middle well (fitc) reagent is light sensitive and exposure to light will degrade the reagent which will potentially cause low patient and quality control recovery.Siemens informed the customer of tsh3-ul light sensitivity, reagent storage and the customer has disabled the led vertical light strips in the refrigerator.The instruction for use (ifu) under the storage and stability states the following: "store reagents in an upright position.Protect the product from heat and light sources.Unopened reagents are stable until the expiration date on the product when stored at 2-8°c." the instruction for use (ifu) under the interpretation of results states the following: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." the assay is performing within specification.No further evaluation of the device is required.
Event or Problem Description
A falsely low atellica im tsh3-ultra (tsh3-ul) result was obtained on a patient sample.The customer observed out of range low quality control issues and performed repeat tsh3-ul testing using a different reagent readypack, resulting higher.Quality control results were within acceptable ranges with the different reagent readypack.Both reagent readypacks were from the same reagent lot 352.The higher tsh3-ul patient result was reported as the correct result.There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant tsh3-ultra (tsh3-ul) result.

• Brand Name: ATELLICA IM TSH3-ULTRA (TSH3-UL)
• Common Device Name: TSH3-UL IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 10054056
• Report Number: 1219913-2020-00112
• Device Sequence Number: 11602553
• Product Code: JLW
• UDI-Device Identifier: 00630414600178
• UDI-Public: 00630414600178
• Combination Product (Y/N): N
• 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): 05/13/2020

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: 01/20/2021
• Device Model Number: N/A
• Device Catalogue Number: 10995704
• Device Lot Number: 352
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2020
• Initial Report FDA Received Date: 05/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1