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

Model Number	6802153
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that lower than expected vitros ammonia (amon) results were obtained from a vitros liquid performance verifier processed using vitros chemistry products amon slides lot: 1018-0257-6733 on a vitros 350 chemistry system.The assignable cause of the lower than expected vitros amon results is an instrument issue related to microslide incubator contamination.The results of a vitros amon within run precision test were not within expectations.Additionally, historical qc results were imprecise.The customer performed maintenance actions on the vitros 350 system which included cleaning the microslide incubator, replacing the evaporation caps and performing correction factors.Following maintenance actions, the results of a vitros amon within run precision test were within ortho acceptable guidelines.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected vitros ammonia (amon) results were obtained from a vitros liquid performance verifier processed using vitros chemistry products amon slides lot: 1018-0257-6733 on a vitros 350 chemistry system.Vitros lpv ii lot: x9323 results of 136.0, 147.0 and 143.0 umol/l versus an expected result of 186.2 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 lower than expected vitros amon results were obtained when processing a control fluid during precision testing.No results were reported out of the laboratory.Ortho was not 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).

• 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 ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 16302871
• Report Number: 0001319681-2023-00009
• Device Sequence Number: 17840658
• Product Code: JJE
• UDI-Device Identifier: 10758750002054
• UDI-Public: 10758750002054
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (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): 02/03/2023

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 Model Number: 6802153
• 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: 01/10/2023
• Initial Report FDA Received Date: 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2016
• 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