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

Model Number	6801732
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected vitros iga results were obtained from two levels of non-vitros biorad quality control fluids processed using vitros chemistry products iga reagent lot 1503-12-1578 on a vitros 4600 chemistry system.Non-vitros biorad immunology level 1 qc lot 85701 results of <40.00, <40.00, <40.00, and <40.00 ug/ml versus the expected result of 115.413 ug/ml non-vitros biorad immunology level 3 qc lot 85703 results of 184.70, 178.39, 176.11, and 178.38 ug/ml versus the expected result of 301.726 ug/ml 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 iga results were obtained from a control fluid and were not reported out of the laboratory.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 (b)(4).
Additional Manufacturer Narrative
The investigation determined that lower than expected vitros iga results were obtained from two levels of non-vitros biorad quality control fluids processed using vitros chemistry products iga reagent lot 1503-12-1578 on a vitros 4600 chemistry system.The assignable cause of the lower than expected vitros iga results is an unknown issue with the reagent pack in question.All of the lower than expected results were obtained using the same reagent pack, sequence # 2997.An issue with the non-vitros biorad quality control fluid used is not a contributor to the event as the customer used the same quality control fluid to test vitros iga lot 1503-12-1578 on an alternate analyzer in the laboratory and the results were as expected.An issue with the vitros 4600 chemistry system is not a contributor to the event as the customer switched back to a previous reagent pack that was in use (pack sequence 2994) and processed their non-vitros biorad quality control fluids, which were in range with no actions performed on the analyzer.Ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros chemistry products iga reagent lot 1503-12-1578.

• Brand Name: VITROS CHEMISTRY PRODUCTS IGA REAGENT
• Common Device Name: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 1000 lee road; rochester NY 14606
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS, INC.; 1000 lee road; rochester NY 14606
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 18608180
• Report Number: 1319808-2024-00001
• Device Sequence Number: 21086786
• Product Code: CFN
• UDI-Device Identifier: 10758750006816
• UDI-Public: 10758750006816
• 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): 01/30/2024

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: 07/01/2024
• Device Model Number: 6801732
• Device Catalogue Number: 6801732
• Device Lot Number: 1503-12-1578
• 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: 01/02/2024
• Initial Report FDA Received Date: 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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