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

Catalog Number	6802783
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report discordant false negative vitros anti-hav igm (ahavm) and vitros anti-hbc igm (ahbcm) results were obtained when tested using a non-vitros (biorad) virotrol iii quality control (qc) fluid lot 124480 on a vitros 3600 immunodiagnostic system.Vitros ahavm results of 0.01 and 0.01 s/c (non-reactive) versus expected results of 2.34 s/c (reactive) vitros ahbcm results of 0.03, 0.03, 0.71, 0.76, 0.74, 0.77, 0.81, 0.85 and 0.83 s/c (non-reactive) versus expected results of 1.44 s/c (reactive) biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The discordant false negative vitros ahavm and ahbcm results were obtained from a non-patient fluid.There was no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint numbers: (b)(4).
Additional Manufacturer Narrative
The investigation has determined that discordant false negative vitros anti-hav igm (ahavm) and vitros anti-hbc igm (ahbcm) results were obtained when tested using a non-vitros (biorad) virotrol iii quality control (qc) fluid lot: 124480 on a vitros 3600 immunodiagnostic system.The assignable cause of the event is an instrument issue.The customer obtained several condition codes when processing vitros ahavm and vitros ahbcm reagent with virotrol iii (positive) quality control fluid.Additionally, a vitros ahbcm precision test was performed and the results were found to be outside of ortho acceptable guidelines, indicating that the vitros 3600 immunodiagnostic system was not performing as expected at the time of the events.An ortho field engineer (fe) performed service actions on the vitros 3600 immunodiagnostic instrument that included replacing the final well wash stepper motor, both signal reagent (sr) tips, both aspirate filters, and the uia metering z guide; and cleaned and optimized the micro well and metering adjustments, which resolved the error codes displayed by the instrument.Qc fluid testing results were returned to expectation following the service actions.The vitros 3600 immunodiagnostic system was returned to expected performance in combination with vitros ahavm and vitros ahbcm.

• Brand Name: VITROS 3600 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: 21461816
• Report Number: 1319681-2025-00011
• Device Sequence Number: 7642317
• Product Code: JJE
• UDI-Device Identifier: 10758750002979
• UDI-Public: (01)10758750002979
• 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): 02/25/2025

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: 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: 01/30/2025
• Initial Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2019
• 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