MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS 350 CHEMISTRY SYSTEM; CHEMISTRY ANALYZER

Catalog Number	6802153
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a higher than expected vitros ammonia (amon) result was obtained from a vitros liquid performance verifier (lpv) processed using vitros chemistry products amon slides lot 1020-0265-3649 on a vitros 350 chemistry system.Vitros lpv i lot d1516 result of 112.3 umol/l versus an expected result of 42.6 umol/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 amon result was obtained when processing a control fluid during precision testing.No results were reported out of 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 (b)(4).
Additional Manufacturer Narrative
The investigation determined that a higher than expected vitros ammonia (amon) result was obtained from a vitros liquid performance verifier (lpv) processed using vitros chemistry products amon slides lot 1020-0265-3649 on a vitros 350 chemistry system.The assignable cause of the higher than expected vitros amon result is an instrument issue related to microslide incubator contamination.The results of a vitros amon within run precision test were not within expectations.The cause of the microslide incubator contamination is likely due to user error as the customer had been using ammonia based cleaning products on the analyzer cabinetry, on the outside of the analyzer prior to the event.The customer performed maintenance actions on the vitros 350 system which included replacing the evaporation caps and cleaning the incubator slots.Following maintenance actions, the results of a vitros amon precision test were within ortho acceptable guidelines.Additionally, following a recalibration event, vitros lpv fluid results were acceptable verifying vitros reagent and instrument performance.

• Brand Name: VITROS 350 CHEMISTRY 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: 20128832
• Report Number: 1319681-2024-00049
• Device Sequence Number: 15324064
• Product Code: JJE
• UDI-Device Identifier: 10758750002054
• UDI-Public: (01)10758750002054
• 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): 09/03/2024

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: 6802153
• 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: 08/09/2024
• Initial Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2013
• 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