MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK; IN VITRO DIAGNOSTICS

Model Number	1387000
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that higher than expected ft4 results were obtained when a l1 vitros ftc (lot 0761) was processed using vitros ft4 lot 5300 on a vitros 5600 integrated system.The assignable cause of the event was not determined.There was limited historical qc data available to assess vitros ft4 reagent assay performance as the instrument had been recently installed at the customer site.However, vitros ft4 lot 5300 results from two levels of vitros ftcs were biased high, therefore a vitros ft4 lot 5300 reagent issue cannot be ruled out as a contributor to the event.The customer received an alternate lot of vitros ft4 reagent (lot 5333) and vitros ftc results were acceptable from this lot.An instrument issue cannot be ruled out as a contributor to the event, as no diagnostic precision testing was conducted around the time of the event to verify the performance of the instrument.Improper pre-analytical handling is an unlikely contributor to the higher than expected vitros ft4 results, as it was confirmed that the customer follows the correct protocol for vitros ftc pre-analytical fluid handling.
Event or Problem Description
The customer reported that higher than expected ft4 results were obtained when a level 1 control from vitros free thyroid control (ftc) lot 0761 was processed using vitros ft4 reagent lot 5300 on a vitros 5600 integrated system.Vitros ftc level 1 = 1.07, 1.19, 1.13, 1.10, 1.11, 1.08 ng/dl versus the pi mean 0.75 ng/dl biased results of the magnitude and direction observed may lead to inappropriate physician action if the results were to recur undetected.The higher than expected vitros ft4 results were generated from non-patient fluids, however the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected.There were no allegations of patient harm as a result of the event.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4)/reportability assessment (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK
• Common Device Name: IN VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; felindre meadows; pencoed; bridgend CF35 5PZ; UK CF35 5PZ
• 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: 17772483
• Report Number: 3007111389-2023-00163
• Device Sequence Number: 17932938
• Product Code: CEC
• UDI-Device Identifier: 10758750008971
• UDI-Public: 10758750008971
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2023

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: 02/07/2024
• Device Model Number: 1387000
• Device Catalogue Number: 1387000
• Device Lot Number: 5300
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 09/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2023
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown