MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS 3600 IMMUNODIAGNOSTIC SYSTEM; CLINICAL CHEMISTRY

Catalog Number	6802783
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	05/19/2026
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 single patient sample when tested on a vitros 3600 immunodiagnostic system.The assignable cause of the event was user error.The customer was using a chlorine-containing disinfectant on the floor surrounding their vitros 3600 immunodiagnostic system.As per vitros 3600 reference guide, cleaning solutions warning: sodium hypochlorite solution, bleach, ammonia, any ammonia (chlorine) containing compound and any other oxidizing agents may be hazardous, may cause erroneous results, and may also corrode metal parts.Therefore, it is not recommended that laboratories utilize cleaning solutions containing chlorine around their vitros analyzers.As no quality control results were provided by the customer upon request, a vitros tropi es lot 6260 performance issue cannot be ruled out as a contributor to the event.However, continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros tropi es reagent lot 6260.Pre-analytical sample processing could not be ruled out as a contributing factor as it is unknown if the customer was following the sample collection device manufacturer recommended centrifugation protocol.Improper pre-analytical sample handling could have contributed to the event.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.
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 single patient sample when tested on a vitros 3600 immunodiagnostic system.Patient sample 1 result of 0.057 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 not reported from the laboratory and 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).

• Brand Name: VITROS 3600 IMMUNODIAGNOSTIC SYSTEM
• Common Device Name: CLINICAL CHEMISTRY
• 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: nancy hewitson ; 100 indigo creek drive; rochester, NY 14626 ; 5854534165
• MDR Report Key: 25375885
• Report Number: 1319681-2026-00037
• Device Sequence Number: 21470630
• Product Code: JJE
• UDI-Device Identifier: 10758750002979
• UDI-Public: (01)10758750002979
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/01/2026

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: 6802783
• 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: 05/19/2026
• Initial Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2017
• 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