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	09/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report reproducible higher than expected vitros ft4 results and reproducible lower than expected vitros tsh results were obtained from a single patient sample tested on a vitros 5600 integrated system when compared to ft4 and tsh results obtained from the same sample tested with a non-vitros roche cobas method.Patient sample 2 vitros ft4 results of 3.73 and 3.85 ng/dl vs.The roche cobas ft4 result of 0.77 ng/dl.Patient sample 2 vitros tsh results of 1.73 and 1.72 ng/dl vs.The roche cobas tsh result of 17.3 ng/dl.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The vitros ft4 and tsh results obtained from the patient sample were reported outside of the laboratory.The customer stated that no corrected reports were issued, however, no treatment was stopped, started or altered based on the vitros ft4 and tsh results reported.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 numbers (b)(4) and reportability assessment (b)(4).
Additional Manufacturer Narrative
A customer reported that reproducible higher than expected vitros ft4 results and reproducible lower than expected vitros tsh results were obtained from a single patient sample tested on a vitros 5600 integrated system when compared to ft4 and tsh results obtained from the same sample tested with a non-vitros roche cobas method.The assignable cause of the event is unknown.An unknown sample specific interferent that affects the vitros assays but not the roche cobas assays cannot be ruled out.The results are reproducible on two different vitros instruments indicating the results are the expected results using the vitros assays.Diagnostic within-lab precision testing was within acceptable guidelines, indicating an instrument related issue did not likely contribute to the event.Historical quality control results indicated both vitros ft4 reagent lot 5560 and vitros tsh reagent lot 7320 were performing as intended on the vitros 5600 system.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic performance issue with either vitros ft4 reagent lot 5560 or vitros tsh reagent lot 7320.

• 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 ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 20399423
• Report Number: 3007111389-2024-00191
• Device Sequence Number: 3492580
• Product Code: CEC
• UDI-Device Identifier: 10758750008971
• UDI-Public: (01)10758750008971(17)250101(11)240418(10)5560
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 10/08/2024

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: 01/01/2025
• Device Catalogue Number: 1387000
• Device Lot Number: 5560
• 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: 09/11/2024
• Initial Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2024
• 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