MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS 5600 INTEGRATED SYSTEM; CHEMISTRY ANALYZER

Catalog Number 6802413

Device Problem Low Test Results (2458)

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

Event Date 02/24/2024

Event Type  malfunction  

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected free t4 (ft4) results were obtained when the customer processed a non-vitros (mas) level 1 qc using vitros ft4 lot 5400 on a vitros 5600 integrated system.Mas lia2490a level 1 results of 1.24, 1.36, 1.16, 1.17, 1.17, 1.23 and 1.16 ng/dl versus the baseline mean value of 2.52 ng/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 ft4 results were obtained when the customer was processing a non-patient fluid.There has been 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).

Manufacturer Narrative

The investigation determined that lower than expected free t4 (ft4) results were obtained when the customer processed a non-vitros (mas) level 1 qc using vitros ft4 lot 5400 on a vitros 5600 integrated system.The cause of the event was an instrument related issue, specifically an issue with a kink observed in the uwr tubing.Vitros b12 and vitros b-hcg ii results were also deemed unacceptable around the time of the event and once the issue with the uwr tubing was resolved, vitros ft4, vitros b12 and vitros b-hcg ii results from mas qc testing returned acceptable results.Historical qc results indicated acceptable vitros ft4 lot 5400 reagent performance and qc results since the correction to the uwr tubing were acceptable.

• Brand Name: VITROS 5600 INTEGRATED SYSTEM
• Type of Device: CHEMISTRY ANALYZER
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 18954542
• MDR Text Key: 339323258
• Report Number: 1319681-2024-00023
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 10758750002740
• UDI-Public: 10758750002740
• 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: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6802413
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1