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

Catalog Number 8298671

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/24/2024

Event Type  malfunction  

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected vitros phenytoin (phyt) results were obtained when processing vitros tdm performance verifiers and non-vitros biorad quality control fluids on a vitros xt7600 system.Vitros phyt slide lot 2627-0187-7862: (b)(6) 2024: vitros tdm pv3 result 32.6 ug/ml versus the midpoint of the rom 25.9 ug/ml.Vitros phyt slide lot 2627-0187-0219: (b)(6) 2024 vitros phyt results 18.98 and 18.86 ug/ml versus the baseline mean of 12.23 ug/ml.(b)(6) 2024 vitros tdm pv3 result of 31.8 ug/ml versus the midpoint of the range of means 25.9 ug/ml.(b)(6) 2024: vitros tdm pv3 result 31.4 ug/ml versus the midpoint of the rom 25.9 ug/ml.(b)(6) 2024: vitros tdm pv3 results >40, >40, >40, >40, >40, >40, >40, >40, >40, >40, >40, >40, >40, >40, >40, >40, >40, 31.9, 34.8, 34.3, 33.5, and 34.3 ug/ml ug/ml versus the midpoint of the range of means 25.9 ug/ml.(b)(6) 2024: vitros biorad multiqual unassayed qc lot 92963 vitros phyt results 32.0, 31.4, 31.6, 32.0, 31.7, 31.1, 32.0, 32.1, 30.8, 31.7, 32.5, 30.6, 31.7, 32.1, 31.1, 31.2, and 31.6 ug/ml versus the customer baseline mean 25.0 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 higher than expected vitros phyt results were obtained when processing quality control fluids.There was no allegation of patient harm as a result of this event.This report is number three of four mdrs for this event.Four 3500a forms are being submitted for this event as four devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).

Manufacturer Narrative

The investigation determined that higher than expected vitros phenytoin (phyt) results were obtained when processing vitros tdm performance verifiers and non-vitros biorad quality control fluids on a vitros xt7600 system.The cause of the higher than expected vitros phyt results from (b)(6), (b)(6) 2024 and (b)(6) 2024 were user error, where the customer processed the assay using an vitros immuno-wash fluid (iwf) lot different from the iwf lot in use when the calibration occurred.The customer inadvertently restored a previous calibration that was processed using the previous vitros iwf lot.The vitros phyt instructions for use states that a calibration is required when the iwf lot number changes.Using a different iwf lot without calibrating can affect assay results.The cause of the higher than expected vitros phyt lot 2627-0187-7862 results from (b)(6) 2024 and the phyt lot 2627-0187-0219 results from (b)(6) 2024 could not be determined.A diagnostic within precision test was performed using slide lot 2627-0187-0219 and results were acceptable indicating the vitros xt7600 system is performing as intended and is not a contributor to the event.A review of historical quality control results across both vitros phyt slide lots indicates overall day to day imprecision.However, as the diagnostic within run precision results were acceptable, it was concluded that quality control fluid handling is a potential contributor to the observed day to day imprecision.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros product phyt, lot 2627-0187-0219 or slide lot 2627-0187-7862.

• Brand Name: VITROS CHEMISTRY PRODUCTS PHYT SLIDES
• Type of Device: 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: 19159815
• MDR Text Key: 341602766
• Report Number: 1319809-2024-00044
• Device Sequence Number: 1
• Product Code: DIP
• UDI-Device Identifier: 10758750004690
• UDI-Public: 10758750004690
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8298671
• Device Lot Number: 2627-0187-0219
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1