MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS 4600 CHEMISTRY SYSTEM; CHEMISTRY ANALYZER

Model Number	6802445
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher and lower than expected results were obtained from a single level of vitros liquid performance verifier (lpv) ii fluid, lot x9323, and a single level of non-vitros biorad ethanol/ammonia control, lot 54370, using two different vitros ammonia (amon) slide lots (1020-0262-4476 and 1019-0263-9036) on a vitros 4600 chemistry system.Vitros amon slide lot 1020-0262-4476 biorad level 3 amon results of 186.5 and 286.5 vs.The expected result of 237.28.1 mol/l.Vitros amon slide, lot 1019-0263-9036, vitros lpv ii amon results of 144.8, 145.1, 158.4, 149.9, 158.0, 143.2, 130.7 and 148.1 vs.The expected result of 198.2 mol/l biorad level 3 amon results of 185.0 and 189.8 vs.The expected result of 237.28.1 mol/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.There was no report of affected patient results and there was no allegation of patient harm.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).
Additional Manufacturer Narrative
The investigation concluded that higher and lower than expected results were obtained from a single level of vitros liquid performance verifier (lpv) ii fluid, lot x9323, and a single level of non-vitros biorad ethanol/ammonia control, lot 54370, using two different vitros ammonia (amon) slide lots (1020-0262-4476 and 1019-0263-9036) on a vitros 4600 chemistry system.The assignable cause of the event was determined to be an instrument related issue likely due to ammonia contamination of the microslide incubator.The cause of the ammonia incubator contamination was not determined.Vitros amon within run precision testing was unacceptable and atypical within-lab vitros amon qc performance was observed on both the vitros amon slide lots.An ortho field engineer is scheduled to go onsite to perform an incubator decontamination procedure, which is expected to resolve the issue.

• Brand Name: VITROS 4600 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: 16737177
• Report Number: 0001319681-2023-00024
• Device Sequence Number: 6673832
• Product Code: JJE
• UDI-Device Identifier: 10758750012343
• UDI-Public: 10758750012343
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 04/13/2023

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: 6802445
• Device Catalogue Number: 6802445
• 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: 03/19/2023
• Initial Report FDA Received Date: 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2016
• 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