MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS BUBC SLIDES; IN-VITRO DIAGNOSTICS

Catalog Number	8383051
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solutions center (tsc) to report that vitros bu quality control results obtained from a single vitros performance verifier (pv) fluid were lower than expected for when using two different lots of vitros bubc microslides tested on a vitros xt 7600 integrated system and a vitros xt 3400 chemistry system.J1 (s/n (b)(6)) with vitros bubc lot 0243-0474-4749 vitros pv ii w1667 bu results 0.0, 0.0, 0.0, 0.0 mg/dl versus the range of means midpoint result of 8.5 mg/dl.J2 (s/n (b)(6)) using vitros bubc lot 0243-0474-1655 vitros pv ii w1667 bu results 0.0 mg/dl versus the range of means midpoint result of 8.5 mg/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 bu results were obtained from a non-patient quality control fluid.There were no allegations of patient harm as a result of the event.This report is number four of five mdr's for this event.Five 3500a forms are being submitted for this event as five devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).
Additional Manufacturer Narrative
The investigation determined lower than expected vitros bu results were obtained from a vitros performance verifier ii lot w1667 fluid tested using two lots of vitros bubc microslides on a vitros xt 7600 integrated system and a vitros xt 3400 chemistry system.The assignable cause of the event is unable to be determined.Historical qc for j1 (xt 7600 system) was inaccurate and imprecise, and the limited qc data for j2 (xt 3400) demonstrated inaccuracy, indicating unacceptable performance for vitros bubc microslide lots 0243-0474-4749 and 0243-0474-1655 when using the performance verifier (pv) fluids.Continual tracking and trending has not identified any signals that would indicate a systemic issue with vitros bubc microslide lots 0243-0474-4749 and 0243-0474-1655.The customer did not provide their vitros pv fluid handling protocol; therefore, it is unknown if the fluids were prepared and handled per the instructions for use, and a vitros pv fluid related issue cannot be ruled out as a contributor to the event.It is possible the affected vitros pv ii lot w1667 fluid was reconstituted incorrectly, stored incorrectly or processed greater than 3 days (stability) after reconstitution.There was no diagnostic precision testing performed on vitros j1 or j2 and therefore an analyzer issue cannot be ruled out as a contributor to the event.

• Brand Name: VITROS CHEMISTRY PRODUCTS BUBC SLIDES
• 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, INC.; 513 technology boulevard; rochester NY 14626
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 21125394
• Report Number: 1319809-2025-00005
• Device Sequence Number: 7583427
• Product Code: CIG
• UDI-Device Identifier: 10758750004829
• UDI-Public: (01)10758750004829(17)260101(11)240727(10)024304744749
• 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): 01/09/2025

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: 01/01/2026
• Device Catalogue Number: 8383051
• Device Lot Number: 0243-0474-4749
• 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: 12/12/2024
• Initial Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2024
• 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