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

Catalog Number	1922814
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that higher than expected tsh results were obtained when three levels of vitros ttcs (lot 0920) were testing using vitros tsh lot 7420 on a vitros eciq immunodiagnostic system.The most likely cause of the event is an instrument related issue.A pre-service within-run tsh precision test failed on the instrument from which the higher than expected vitros tsh results identified as meeting potential health and safety criteria were obtained.An ortho field engineer (fe) optimized all modules on the vitros eciq immunodiagnostic system and performed incubator adjustments, well wash adjustments, an incubator reference system (irs) calibration, reagent mirroring, sample metering adjustments and cleaning of the microwell incubator.In addition, the ortho fe rebuilt the well shuttle and made all necessary well shuttle adjustments.Post service precision testing was deemed acceptable and the customer has not reported any further issues with results on their vitros eciq immunodiagnostic system.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected tsh results were obtained when three levels of vitros ttcs (lot 0920) were testing using vitros tsh lot 7420 on a vitros eciq immunodiagnostic system.Level 1 results of 0.197, 0.237, 0.159 and 0.153 miu/l versus the package insert mean result of 0.042 miu/l level 2 results of 3.18, 2.98, 3.01, 3.00 and 3.03 miu/l versus the package insert mean result of 2.29 miu/l level 3 results of 26.7, 26.6, 27.1, 27.2, 27.1, 27.3, 27.6, 28.4, 26.9, 27.5, 27.4 and 27.5 miu/l versus the package insert mean result of 20.6 miu/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The higher than expected vitros tsh results were obtained when the customer was processing non-patient fluids.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 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 ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 21641444
• Report Number: 1319681-2025-00016
• Device Sequence Number: 15347051
• Product Code: KHO
• UDI-Device Identifier: 10758750000272
• UDI-Public: (01)10758750000272
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 03/18/2025

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: 02/19/2025
• Initial Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2025
• 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