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

Catalog Number	6801059
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that a non-reproducible, lower than expected b-hcg result was obtained from a single patient sample when using vitros immunodiagnostics product b-hcg ii reagent lot 4570 on a vitros eciq system.The result was considered discordant when compared to repeat results obtained from the same patient sample.The assignable cause of the event is user error while interacting with the vitros eciq system.According to the operators manual for the eci q system, when the condition code f02-194 (no fluid was detected during the probe wash or reagent probe wash verification outside acceptable limit) is obtained on the instrument after the system has been idle for less than 8 hours, initialize the eci q system and then process quality control fluids for the assay to be tested prior to processing any patient samples.If the control results are acceptable then you may report patient sample results.If controls are not acceptable or the condition code reappears, do not process patient samples and contact the ortho tsc for assistance.The customer did not process quality controls for vitros b-hcg ii prior to testing the patient sample after the condition code had posted on the instrument after the system was idle for approximately 5 hours.A transient instrument error likely contributed to the initial lower than expected patient sample result.Historical qc fluid performance indicates a vitros b-hcg ii lot 4570 performance issue is not a likely contributor to the event and continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros b-hcg ii lot 4570.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a non-reproducible, lower than expected b-hcg result was obtained from a single patient sample when using vitros immunodiagnostics product b-hcg ii reagent lot 4570 on a vitros eciq system.The result was considered discordant when compared to repeat results obtained from the same patient sample.Patient 1 vitros b-hcg ii result of <2.39 miu/ml vs.The expected result of 57.000 miu/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 b-hcg result was not reported from the laboratory.There was 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 613405.

• Brand Name: VITROS ECI IMMUNODIAGNOSTIC SYSTEM - REFURBISHED
• 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: 24371204
• Report Number: 1319681-2026-00007
• Device Sequence Number: 5018621
• Product Code: KHO
• UDI-Device Identifier: 10758750001040
• UDI-Public: (01)10758750001040
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 02/17/2026

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: 6801059
• 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: 01/20/2026
• Initial Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2026
• 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