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

Catalog Number	1922814
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has determined that a non-reproducible, higher than expected, vitros tropi es result was obtained from a vitros buffer solution (specialty diluent 3) known to be troponin free when tested on a vitros eciq immunodiagnostic system.The most likely cause of the event was determined to be user error due to cleaning maintenance of a non-vitros abbott id now system with chlorine based cleaning solution in the vicinity of the vitros eciq immunodiagnostic system, leading to vapor contamination of the microwell incubator.The vitros eciq immunodiagnostic system in use during the event was operating as intended.The vitros user guide instructs customers not to use chlorine-based cleaning solutions as they have the potential to cause erroneous results on the vitros system.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a non-reproducible, higher than expected vitros tropi es result was obtained from a vitros buffer solution (specialty diluent 3) known to be troponin free when tested on a vitros eciq immunodiagnostic system.Specialty diluent 3 result of 0.059 ng/ml versus the expected result of < 0.012 ng/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The non-reproducible, higher than expected, vitros tropi es result was from non-patient fluid and was not reported from the laboratory.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) and reportability assessment 604354.

• Brand Name: VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM
• Common Device Name: 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 ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 18371560
• Report Number: 0001319681-2023-00064
• Device Sequence Number: 15381530
• Product Code: KHO
• UDI-Device Identifier: 10758750000272
• UDI-Public: 10758750000272
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/21/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 1922814
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2023
• Initial Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown