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

Catalog Number 8298671

Device Problems High Test Results (2457); Low Test Results (2458)

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

Event Date 11/28/2023

Event Type  malfunction  

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower and higher than expected vitros phenytoin (phyt) results were obtained when processing biorad immunoassay plus qc level 3, lot 85310 tested on a vitros xt7600 integrated system.Vitros phyt slides, lot 2626-0186-4393 vitros phyt results 27.9, 29.5, 29.6, 12.8, 13.4, 8.8, and 14.1 ug/ml versus the baseline mean 23.2 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 and lower 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 six of seven mdr¿s for this event.Seven 3500a forms are being submitted for this event as seven devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint numbers (b)(4) and reportability assessment (b)(4).

Manufacturer Narrative

The investigation determined that lower and higher than expected vitros phenytoin (phyt) results were obtained when processing biorad immunoassay plus qc level 3, lot 85310 using phyt lot 2626-0186-4393 on a vitros xt7600 integrated system.The cause of the unacceptable quality control performance could not be determined.A review of historical quality control results obtained when using vitros phyt lot 2626-0186-4393 confirms an issue with both accuracy and within laboratory precision.However, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros product phyt, lot 2626-0186-4393.Historical vitros phyt quality control results for the previous phyt lot 2625-0185-2730 and the current lot 2626-0186-6657 of vitros phyt indicate acceptable accuracy and within laboratory precision.In addition to the acceptable within laboratory precision on the alternate phyt slide lots, a diagnostic within run vitros crbm precision test was acceptable.Therefore, the vitros xt7600 system is not suspected to be a contributor of the event.

• 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 ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 18369371
• MDR Text Key: 331297659
• Report Number: 0001319809-2023-00189
• 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: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2024
• Device Catalogue Number: 8298671
• Device Lot Number: 2626-0186-4393
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1