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

Catalog Number	6802783
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected b-hcg ii results were obtained from a level 3 non-vitros mas omni immune quality control (qc) fluid lot oim2612 when tested using vitros immunodiagnostics product b-hcg ii reagent lot 4350 on a vitros 3600 immunodiagnostic system.Mas lot oim2612 level 3 qc fluid results of 71.374 and 73.815 miu/ml vs.The expected result of 796.320 miu/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The lower than expected vitros b-hcg ii results were from a non-patient fluid and were not reported from the laboratory.The customer did not give any indication that patient results had been affected, and ortho has not been made aware of any 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).
Additional Manufacturer Narrative
The investigation determined that lower than expected b-hcg ii results were obtained from a level 3 non-vitros mas omni immune quality control (qc) fluid lot oim2612 when tested using vitros immunodiagnostics product b-hcg ii reagent lot 4350 on a vitros 3600 immunodiagnostic system.The assignable cause of the lower than expected qc sample results was an instrument related issue as multiple condition codes were obtained on the vitros 3600 system around the timeframe of the event.An ortho field engineer (fe) visited the customer site and performed service and maintenance actions, including a thorough cleaning and decontamination of all analyzer modules.Additionally, the fe replaced various parts, such as well wash aspirate filters, auxiliary bottles, intake filters, dispensing tips of the signal reagent module, and foam pads.Following these actions, the ortho fe performed a post service vitros tsh3 diagnostic precision test on the instrument, which yielded acceptable results, verifying the instrument performance after the service actions.

• 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: 21993130
• Report Number: 1319681-2025-00024
• Device Sequence Number: 4311498
• Product Code: JJE
• UDI-Device Identifier: 10758750002979
• UDI-Public: (01)10758750002979
• 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): 05/07/2025

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: 04/15/2025
• Initial Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2020
• 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