MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T4 REAGENT PACK; IN-VITRO DIAGNOSTICS

Catalog Number 1387000

Device Problem High Test Results (2457)

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

Event Date 10/06/2022

Event Type  malfunction  

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a higher than expected free t4 (ft4) result was obtained from a patient sample when running vitros ft4 reagent on a vitros 5600 integrated system.Patient sample result of 1.03 ng/dl versus the expected result of 0.73 ng/dl.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The higher than expected vitros ft4 result was not reported from laboratory as the sample was repeated for troubleshooting purposes only.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4).

Manufacturer Narrative

The investigation determined that a higher than expected free t4 (ft4) result was obtained from a patient sample when running vitros ft4 reagent on a vitros 5600 integrated system.A definitive assignable cause could not be determined with the information provided.Vitros ft4 reagent lot 5020 was not in use at the customer site and run for troubleshooting purposes only, therefore limited quality control data was available.However, all results that were obtained for this lot were within expectation, indicating that vitros ft4 lot 5020 was performing as expected.Although diagnostic precision testing was not run at the time of the event, there is no indication of an instrument malfunction as the customer continued to obtain acceptable qc results and precision sample repeats.Unexpected instrument performance is not a likely contributor to the event.Pre-analytical sample processing could not be ruled out as a contributing factor, as it was not possible to establish if the customer was following the sample collection device manufacture¿s recommendation for sample centrifugation and cellular debris, due to poor sample preparation, was possibly present in the affected sample, although this could not be confirmed.It is also unknown how the patient sample was stored between the initial and repeat testing, and an issue with the sample storage cannot be ruled out as a contributor to the event.An issue with the reagent pack in use at the time of the higher than expected patient result is not a likely issue as qc fluids were acceptable when run using the same reagent pack.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros ft4 reagent lot 5020.(b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T4 REAGENT PACK
• Type of Device: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO CLINICAL DIAGNOSTICS; felindre meadows; pencoed; bridgend, wales CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 15722004
• MDR Text Key: 307698546
• Report Number: 3007111389-2022-00193
• Device Sequence Number: 1
• Product Code: CEC
• 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
• Type of Report: Initial
• Report Date: 11/02/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2023
• Device Catalogue Number: 1387000
• Device Lot Number: 5020
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/07/2022
• Initial Date FDA Received: 11/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1