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

Catalog Number 8298671

Device Problem Low Test Results (2458)

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

Event Date 03/12/2024

Event Type  malfunction  

Event Description

The investigation concludes that a discordant low vitros phenytoin (phyt) result was obtained when processing a college of american pathologists (cap) proficiency fluids using two different vitros phyt slide lots on a vitros xt 7600 system.Cap was still compiling data and was unable to provide the expected result for this proficiency fluid.Therefore, the expected result was the phyt result obtained from the in use phyt slide lot 2626-0186-6657.Vitros phyt lot 2627-0187-9131 result of 24.2 ug/ml versus the vitros phyt lot 2626-0186-6657 result of 31.6 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 discordant low vitros phyt result was obtained when processing proficiency fluids.There was no allegation of patient harm as a result of this event.

Manufacturer Narrative

The investigation concludes that a discordant low vitros phenytoin (phyt) result was obtained when processing a college of american pathologists (cap) proficiency fluids using two different vitros phyt slide lots on a vitros xt 7600 system.The cause of the discordant low vitros phyt result could not be determined.The acceptable vitros tdm performance verifier results indicate vitros phyt slide lot 2627-0187-9131 in combination with the vitros xt 7600 system is performing as expected.In addition to the acceptable vitros tdm performance verifier results, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros phyt slide lot 2627-0187-9131.It is unknown how the customer completed the correlation test using cap proficiency fluids after the calibration event on (b)(6) 2024.The time frame between test events on the two phyt slide lots as well as sample handling and storage were not provided.Therefore, sample handling cannot be ruled out or confirmed as a contributor of the vitros phyt result obtained after the calibration event.

• Brand Name: VITROS CHEMISTRY PRODUCTS PHYT SLIDES
• Type of Device: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC ROCHESTER; 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: 19080171
• MDR Text Key: 340700880
• Report Number: 1319809-2024-00038
• 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: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2024
• 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: 2627-0187-9131
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1