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

Model Number	6802153
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined higher than expected results were obtained from a single level of vitros liquid performance verifier (lcv) i, lot b9937, using vitros ammonia (amon) slide lot 1020-0262-5362 tested on a vitros 350 chemistry system.Results of precision testing demonstrated ammonia contamination of the incubator subsystem of the vitros 350 chemistry system was the assignable cause of the event.Acceptable vitros amon performance was obtained after performing an incubator decontamination procedure and cleaning the incubator evaporation caps of the vitros 350 chemistry system.The ammonia incubator contamination was most likely caused by the customer using the improper protocol of using an ammonia-based cleaner in the laboratory where the vitros 350 chemistry system resides.The vitros 350 chemistry system operator¿s manual states to never use ammonia cleaners on or near the analyzer.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected results from a single level of vitros liquid performance verifier (lcv) i, lot b9937, using vitros ammonia (amon) slide lot 1020-0262-5362 tested on a vitros 350 chemistry system.Vitros lpv i b9937 results of 108.8, 117.1, 128.6, 105.4, 102.6, 101.7, 124.7, 140.7, 138.1, 117.1, 93.7, 117.1, 94.8, 99.9 and 117.2 umol/l compared to an expected result of 45.6 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 results were obtained from a non-patient vitros lpv quality control fluid.There was no reported 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).

• 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: 16715570
• Report Number: 0001319681-2023-00023
• Device Sequence Number: 7264181
• Product Code: JJE
• UDI-Device Identifier: 10758750002054
• UDI-Public: 10758750002054
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/11/2023

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: 03/14/2023
• Initial Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2015
• 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