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

Model Number	1728872
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected free t4 (ft4) results were obtained from a patient sample and from a vitros free thyroid quality control fluid when running vitros ft4 reagent on a vitros 5600 integrated system.Patient sample result of 1.01 ng/dl versus the expected result of 0.71 ng/dl vitros free thyroid control lot 0761 result of 1.18 ng/dl versus the expected result of 0.75 ng/dl 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 obtained from qc fluid and from repeat patient testing and were not reported from laboratory as the sample was repeated for troubleshooting purposes only.There was no 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 602528.
Additional Manufacturer Narrative
The investigation determined that higher than expected free t4 (ft4) results were obtained from a patient sample and from a vitros free thyroid quality control fluid when running vitros ft4 reagent on a vitros 5600 integrated system.The assignable cause of the event was incorrect preparation of the vitros ft4 calibrators.All unexpected results were obtained on calibration curves from calibrators that were prepared using reagent grade water.Per the vitrso ft4 instructions for use (ifu), distilled water is to be used for reconstitution.When the customer prepared the calibrators per the ifu, the patient and controls results were within expectation.Vitros ft4 reagent lot 5240 was a new lot at the customer site and therefore historical qc was not available, however the initial biorad qc run on this lot and the vitros ft4 qc were higher than expected when processed on the calibration that was not made per ifu specifications using reagent grade water.When a calibration was performed per ifu specifications using distilled water, results for both the biorad qc and the vitros ft4 qc were within expectation.A diagnostic vitros tt4 precision test was acceptable, indicating that unexpected instrument performance is not a likely contributor 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 5240.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T4 CALIBRATORS
• 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: 17316922
• Report Number: 3007111389-2023-00117
• Device Sequence Number: 19832540
• Product Code: CEC
• UDI-Device Identifier: 10758750000029
• UDI-Public: 10758750000029
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 07/13/2023

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: 1728872
• Device Catalogue Number: 1728872
• Device Lot Number: 5240
• 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: 06/19/2023
• Initial Report FDA Received Date: 07/13/2023
• 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