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

Catalog Number	6802413
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report discordant, reactive vitros syphilis (syph) results were obtained from three samples from a single patient when processed using vitros immunodiagnostic products syph tpa reagent lots 1760 and 1790 on a vitros 5600 integrated system - refurbished.The results were discordant when compared to the results from the second sample for the patient processed using an alternate vitros 5600 system at the site as well as a negative rapid plasma reagin (rpr) result for the patient.Vitros syph lot 1760 patient 1 sample 1 results of 1.48 and 1.61 s/c (reactive) versus the expected result of 0.57 s/c (non-reactive) patient 1 sample 2 results of 1.66, 1.75, 1.75, 1.32, 1.57, 1.70 and 1.76 s/c (reactive) versus the expected result of 0.57 s/c (non-reactive) vitros syph lot 1790 patient 1 sample 3 results of 1.69, 1.96 and 1.99 s/c (reactive) versus the expected result of 0.57 s/c (non-reactive) biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The discordant, false reactive vitros syph donor sample results were not reported from the laboratory.There has been no reported allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint numbers (b)(4) and reportability assessment (b)(4).
Additional Manufacturer Narrative
The investigation has determined that discordant, reactive vitros syphilis (syph) results were obtained from three samples from a single patient when processed using vitros immunodiagnostic products syph tpa reagent lots 1760 and 1790 on a vitros 5600 integrated system - refurbished.The results were discordant when compared to the results from the second sample for the patient processed using an alternate vitros 5600 system at the site as well as a negative rapid plasma reagin (rpr) result for the patient.The assignable cause of the event is an instrument related issue due to user error.The flooring of the laboratory in which the vitros 5600 system was located had been cleaned using bleach during the timeframe of the event.According to v-docs of the vitros 5600 system, cleaning solutions: do not use any solvents or cleaning solutions on any part of the vitros system, other than distilled or deionized water.Never use ammonia cleaners on or near the vitros system.Warning: sodium hypochlorite solution, bleach, ammonia, any ammonia-containing compound and any other oxidizing agents may be hazardous, may cause erroneous results, and may also corrode metal parts.Therefore, 70% isopropyl alcohol-in-water is recommended.Observe all precautionary handling instructions on the manufacturers package.Acceptable results for the patient were obtained from sample 2 when processed on the sites alternate vitros 5600 system using vitros syph tpa reagent lot 1790.The alternate vitros instrument was in another laboratory on a different floor at the customer site.The flooring of the other laboratory had not been cleaned using bleach.

• Brand Name: VITROS 5600 INTEGRATED 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: nancy hewitson ; 100 indigo creek drive; rochester, NY 14626 ; 5854534165
• MDR Report Key: 24316976
• Report Number: 1319681-2026-00006
• Device Sequence Number: 17536052
• Product Code: JJE
• UDI-Device Identifier: 10758750002740
• UDI-Public: (01)10758750002740
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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): 02/11/2026

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: 6802413
• 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: 11/05/2025
• Initial Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2018
• 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