MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK; IN-VITRO DIAGNOSTICS

Catalog Number 6802301

Device Problem Low Test Results (2458)

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

Event Date 12/26/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that lower than expected, vitros troponin i es (tropi es) results were obtained from a single patient sample when tested on three different vitros xt 7600 integrated systems.A definitive assignable cause could not be determined with the information provided.Reported qc fluid performance indicates a vitros tropi es performance issue is not a likely contributor to the event.However, the customer does not process a control fluid with a troponin i concentration at, or below the url.Therefore, the performance of the vitros tropi es reagents, or below the url concentration of 0.034 ng/ml cannot be determined and a reagent issue could not be entirely ruled out as contributing to the event.Furthermore, precision testing of the vitros xt 7600 integrated systems was not performed when requested.Therefore, it cannot be confirmed that the instruments were operating as intended and unexpected instrument performance cannot be completely ruled out as contributing to the event.In addition, 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.Improper pre-analytical sample handling could have contributed to this event.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.Sample mix up also cannot be ruled out as contributing to this event.Continual tracking and trending of complaints has not identified any signals that would point to potential systemic issues with vitros tropi es, lots 5170, 5270 and 5420.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected, vitros troponin i es (tropi es) results were obtained from a single patient sample when tested on three different vitros xt 7600 integrated systems.Vitros tropi es lot 5170 patient sample 2 result of < 0.012 ng/ml versus the expected result of 10.40 ng/ml vitros tropi es lot 5270 patient sample 2 result of < 0.012, < 0.012 and <0.012 ng/ml versus the expected result of 10.40 ng/ml vitros tropi es lot 5420 patient sample 2 result of < 0.012 ng/ml versus the expected result of 10.40 ng/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The lower than expected, vitros tropi es result of <0.012 ng/ml was reported from the laboratory.However, no treatment was altered, initiated or stopped based on the reported result and ortho has not been made aware of any allegation of patient harm as a result of this event.This report is number two of four mdr¿s 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 604713.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK
• 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; felindre meadows; pencoed; bridgend CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: laurie o'riordan ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 18539867
• MDR Text Key: 333508253
• Report Number: 3007111389-2024-00015
• Device Sequence Number: 1
• Product Code: MMI
• UDI-Device Identifier: 10758750002504
• UDI-Public: 10758750002504
• 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: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2024
• Device Catalogue Number: 6802301
• Device Lot Number: 5270
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1