MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T4 REAGENT PACK; IN-VITRO DIAGNOSTICS

Model Number	1387000
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a lower than expected ft4 result from a single patient sample using a vitros immunodiagnostic products ft4 reagent on a vitros 5600 integrated system.The result was considered lower than expected when compared to a vitros ft4 result from the same sample obtained from a different lot of vitros ft4 reagent.Patient sample 1 result of 1.34 ng/dl versus the expected result of 2.72 ng/dl biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The lower than expected vitros ft4 result was not reported from the laboratory and ortho has not been made aware of any allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).
Additional Manufacturer Narrative
The investigation has determined that a lower than expected ft4 result from a single patient sample using a vitros immunodiagnostic products ft4 reagent on a vitros 5600 integrated system.The result was considered lower than expected when compared to a vitros ft4 result from the same sample obtained from a different lot of vitros ft4 reagent.The assignable cause for the lower than expected vitros ft4 results could not be determined with the information provided.Instrument performance is not a likely contributor to the events.However, it cannot be entirely ruled out as a contributing factor as precision testing to assess instrument performance was not performed by the customer.In addition, pre-analytical sample processing could not be ruled out as a contributing factor, as it could not be established if the customer was following the sample collection device manufacture¿s recommendation for sample centrifugation and cellular debris, due to poor sample preparation, was likely present in the affected sample, although this could not be confirmed.The patient sample was not retested with either lot number to determine if the results were reproducible, therefore, a sample related issue cannot be ruled out as contributing to the event.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros ft4 reagent lot 4223.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T4 REAGENT PACK
• Common Device Name: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS; felindre meadows; pencoed; bridgend CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: laurie o'riordan ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 17208283
• Report Number: 3007111389-2023-00104
• Device Sequence Number: 20481055
• Product Code: CEC
• UDI-Device Identifier: 10758750008971
• UDI-Public: 10758750008971
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2023

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: 11/02/2023
• Device Model Number: 1387000
• Device Catalogue Number: 1387000
• Device Lot Number: 5223
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown