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

Catalog Number	1387000
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected free t4 (ft4) results were obtained from vitros free thyroid control (ftc) fluid when using vitros immunodiagnostic products ft4 reagent on a vitros 5600 integrated system.Ftc level 2 vitros ft4 result of 1.86 ng/dl on inst j1 versus the expected result of 2.46 ng/dl ftc level 2 vitros ft4 results of 1.79 ng/dl on inst j2 versus the expected result of 2.46 ng/dl biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The lower than expected results were obtained from non-patient sample qc fluids.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 numbers (b)(4), (b)(4) and reportability assessment (b)(4).
Additional Manufacturer Narrative
The investigation has determined that lower than expected free t4 (ft4) results were obtained from vitros free thyroid control (ftc) fluid when using vitros immunodiagnostic products ft4 reagent on a vitros 5600 integrated system.The assignable cause for the lower than expected vitros ft4 results could not be determined with the information provided.The low ft4 qc results were isolated to the ftc qc fluids with an unknown lot number.No further investigation of those ftc qc fluids was performed and therefore, an issue with the lot unknown ftc fluids could not be confirmed or ruled out as a potential contributor to the event.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.Pre-analytical sample processing cannot be ruled out as a contributing factor, as it was not clearly determined if the customer was following the correct recommendation for control storage, preparation and sample handling.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros ft4 reagent lot 5260.

• 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: 17377814
• Report Number: 3007111389-2023-00121
• Device Sequence Number: 15079611
• Product Code: CEC
• UDI-Device Identifier: 10758750008971
• UDI-Public: 10758750008971
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 07/21/2023

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: 01/07/2024
• Device Catalogue Number: 1387000
• Device Lot Number: 5260
• 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: 06/25/2023
• Initial Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2023
• 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