MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS XT 7600 INTEGRATED SYSTEM; IN-VITRO DIAGNOSTICS

Catalog Number	6844461
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that discordant, higher than expected troponin i results were obtained when samples from two different patients were tested using vitros high sensitivity troponin i (hstni) reagent lot 1492 on two different vitros xt7600 integrated systems.The results were considered discordant upon repeat testing of the same patient samples.The assignable cause of the event was an instrument related issue of contamination due to improper protocol.The customer was using hypochlorite (bleach) in the laboratory.According to v-docs of the vitros xt 7600 system: cleaning solutions: "do not use any solvents or cleaning solutions on any part of the vitros instrument other than distilled or deionized water.Never use bleach cleaners on or near the vitros instrument." an ortho field engineer (fe) and field application specialist (fas) performed decontamination of the wells incubator, replaced the absorption pack, installed new universal wash, and thoroughly cleaned and decontaminated both the solid and liquid waste containers on both instruments.In addition, the sr packs were replaced to ensure proper reagent delivery and maintain system cleanliness.Following these corrective actions, the systems were recalibrated for vitros hstni, and both quality controls and patient samples were repeated in replicate.All results reproduced within expected performance ranges.The event was determined to be caused by contamination within the instruments due to the use of bleach (hypochlorite) cleaning agents in the laboratory.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report discordant, higher than expected troponin i results were obtained when samples from two different patients were tested using vitros high sensitivity troponin i (hstni) reagent lot 1492 on two different vitros xt 7600 integrated systems.The results were considered discordant upon repeat testing of the same patient samples.Vitros xt 7600 integrated system: s/n (b)(6) (j1) patient 1, sample 1, vitros hstni result 37.68 ng/l (above cutoff) vs.Expected hstni result of 4.29 ng/l (below cutoff) vitros xt 7600 integrated system: s/n (b)(6) (j2) patient 2, sample 1, vitros hstni result 30.37 ng/l (above cutoff) vs.Expected hstni result of 8.01 ng/l (below cutoff) biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The discordant, higher than expected vitros hstni results were reported by the laboratory; however, the physician later questioned the results.Ortho has not been made aware of any allegation of patient harm related to this event.This report is number two of two mdrs for this event.Two 3500a forms are being submitted for this event as two devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint numbers (b)(4) and reportability assessment (b)(4).

• Brand Name: VITROS XT 7600 INTEGRATED SYSTEM
• Common Device Name: IN-VITRO DIAGNOSTICS
• 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: 24669923
• Report Number: 1319681-2026-00017
• Device Sequence Number: 5042788
• Product Code: JJE
• UDI-Device Identifier: 10758750031610
• UDI-Public: (01)10758750031610
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 03/23/2026

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: 6844461
• 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: 02/24/2026
• Initial Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2019
• 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