MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC ROCHESTER 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	03/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that reproducible, lower than expected ft4 results were obtained when a non-vitros audit microcontrol linearity fluid was processed using vitros ft4 lot 5430 on a vitros xt 7600 integrated system.A definitive cause of the event was not established.A vitros ft4 lot 5430 reagent issue is an unlikely cause of the event as historical qcs leading up to the event indicated acceptable vitros ft4 lot 5430 reagent performance.Additionally, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros ft4 lot 5430.There was no evidence of an instrument malfunction and the vitros ft4 results for all five of the linearity fluids were reproducible on the instrument.However, as no diagnostic precision testing was conducted around the time of the event, an issue with the vitros xt 7600 integrated system cannot be completely ruled out as a contributor to the event.Improper handling of the lb linearity fluid cannot be ruled out as a contributor to the event as no information was provided when requested in relation to the pre-analytical handling of the lb audit microcontrol.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report reproducible, lower than expected ft4 results were obtained when a non-vitros audit microcontrol linearity fluid was processed using vitros ft4 lot 5430 on a vitros xt 7600 integrated system.Audit microcontrol (lot 06997) lb fluid results of 2.00, 2.02 and 2.11 ng/dl verus the peer mean result of 2.75 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 vitros ft4 results were obtained when the customer was processing a non-patient fluid and were not reported from the laboratory.There has been 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 (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T4 REAGENT PACK
• Common Device Name: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC ROCHESTER; 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: 19080115
• Report Number: 3007111389-2024-00076
• Device Sequence Number: 17609974
• Product Code: CEC
• UDI-Device Identifier: 10758750008971
• UDI-Public: 10758750008971
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/10/2024

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: 07/30/2024
• Device Catalogue Number: 1387000
• Device Lot Number: 5430
• 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: 03/14/2024
• Initial Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2023
• 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