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	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that higher than expected ft4 results, were obtained during a patient correlation testing using vitros immunodiagnostics products free t4 (ft4) reagents on a vitros 5600 integrated system.The results were considered discordant when compared to repeat testing performed using a non-vitros beckman method.The assignable cause of the event could not be determined with the information provided.A vitros ft4 lot 6060 and 6100 reagent related issue is not a likely contributor to the event as historical qc fluid results were within expectations.Additionally, ongoing tracking and trending does not indicate any performance concerns with these lots.As no precision testing was performed on the analyzer, its performance at the time of the events cannot be confirmed.However, the customer did not report any instrument malfunction and qc fluid results were within expectations.Based on this information, it is unlikely that the instrument contributed to the events.In addition, pre-analytical sample processing cannot be ruled out as a contributing factor, as it was not established whether the customer followed the sample collection device manufacturers recommendations for centrifugation.Cellular debris, possibly resulting from inadequate sample preparation, may have been present in the affected sample; however, this could not be confirmed.The customer did not provide any patient medication, history or clinical information.At the time of reporting, additional testing was performed using both the vitros method and a non-vitros beckman method.The vitros ft4 results demonstrated a consistent positive bias compared to the non-vitros method.In the absence of information regarding sample handling, patient treatment, or clinical status, it cannot be determined whether the observed differences are attributable to pre-analytical sample handling, method-specific differences, or true physiological variation.Therefore, the root cause of the event cannot be determined.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected ft4 results, were obtained during a patient correlation testing using vitros immunodiagnostics products free t4 (ft4) reagents on a vitros 5600 integrated system.The results were considered discordant when compared to repeat testing performed using a non-vitros beckman method.Vitros 5600 integrated system: s/n (b)(6): patient 1, vitros ft4 lot 6100 result of 18.3 uiu/ml (euthyroid) vs.The expected result of 6.9 uiu/ml (hypothyroid) patient 6, vitros ft4 lot 6100 result of 40.6 uiu/ml (hyperthyroid) vs.The expected result of <5.2 uiu/ml (hypothyroid) biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The higher than expected vitros ft4 results were not reported from the laboratory.There was no allegation of patient harm as a result of this event.This report is number one of two mdrs for this event.Two 3500a forms are being submitted for this event as two devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).

• 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: nancy hewitson ; 100 indigo creek drive; rochester, NY 14626 ; 5854534165
• MDR Report Key: 24583152
• Report Number: 3007111389-2026-00046
• Device Sequence Number: 16033764
• Product Code: CEC
• UDI-Device Identifier: 10758750000227
• UDI-Public: (01)10758750000227(17)260706(11)251111(10)6060
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/12/2026

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: 07/06/2026
• Device Catalogue Number: 1387000
• Device Lot Number: 6060
• 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: 02/13/2026
• Initial Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2025
• 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