MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTICS 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	08/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a lower than expected vitros ft4 result was obtained from a single patient sample using vitros immunodiagnostic products ft4 reagent on a vitros 5600 integrated system.Patient sample 4 result of 1.72 ng/dl vs.The expected result of 2.24 ng/dl biased results of the magnitude and direction observed may lead to inappropriate physician action if the results were to recur undetected.The lower than expected vitros ft4 result was not reported from the laboratory as it was obtained as part of a patient sample correlation.There was no reported allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint numbers (b)(4) and reportability assessment (b)(4).
Additional Manufacturer Narrative
The investigation has determined that a lower than expected vitros ft4 result was obtained from a single patient sample using a vitros immunodiagnostic products ft4 reagent on a vitros 5600 integrated system.The definitive assignable cause of the event was not be determined.The likely contributor to the event is an instrument related issue.An ortho field engineer (fe) performed service & maintenance actions on numerous subsystems including the well wash and signal reagent subsystems.Following service actions, the ortho fe processed performance tests to verify the instrument operation.However, as no pre-service within run precision testing was performed by the customer or the ortho fe to verify the instrument performance prior to service and maintenance actions, it cannot be definitively confirmed that the vitros 5600 integrated system was the cause of the event.It was not possible to establish if the customer is following the sample collection device manufacturer¿s recommended centrifugation protocol.In addition, no details were provided on patient sample handling on the day of the event.Therefore, pre-analytical sample handling cannot be ruled out as a contributing factor.Based on historical quality control results, a vitros ft4 lot 5240 performance issue is not a likely contributor to the event.In addition, continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros ft4 reagent lot 5240.

• Brand Name: VITROS IMMUNODIAGNOSTICS 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: 17780452
• Report Number: 3007111389-2023-00167
• Device Sequence Number: 12135732
• Product Code: CEC
• UDI-Device Identifier: 10758750008971
• UDI-Public: 10758750008971
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/20/2023

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: 12/20/2023
• Device Model Number: 1387000
• Device Catalogue Number: 1387000
• Device Lot Number: 5240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2023
• 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