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

Catalog 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	10/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower and higher than expected results were obtained from two different levels of vitros liquid performance verifier (lpv) fluids, using vitros ammonia (amon) slide lot 1020-0260-1781 on a vitros 4600 chemistry system.Lpv i b9937 results of 345.7 and 339.5 ug/dl vs.The expected result of 77.65 ug/dl.Lpv ii c9938 result of 198.6, 187.7, 239.5, 257.2, 200.2, 223.9, 273.6, 195.9, 247.8, 251.2, 213.3, 114.1, 238.7, 182.1, 267.5, and 273.1 umol/l vs.The expected result of 351.15 ug/dl.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 concludes that lower and higher than expected results were obtained from two different levels of vitros liquid performance verifier (lpv) fluids, using vitros ammonia (amon) slide lot 1020-0260-1781 on a vitros 4600 chemistry system.The assignable cause of the event is an instrument event related to microslide incubator contamination.Results of precision testing demonstrated that the vitros 4600 chemistry system was not operating as expected at the time of the event.Acceptable vitros amon performance was obtained after an ortho field engineer performed the following service actions to the vitros 4600 integrated system: performing a decontamination of the microslide incubator, replacing the incubator evaporation caps, performing eject and insert blade adjustments, performing a read/sync adjustment, processing correction factor slides and updated the factors and calibrating vitros amon slide lot 1020-0260-1781.

• 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: 18162168
• Report Number: 0001319681-2023-00061
• Device Sequence Number: 15115075
• Product Code: JJE
• UDI-Device Identifier: 10758750012343
• UDI-Public: 10758750012343
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• Number of Events Summarized: 1
• Summary Report (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): 11/17/2023

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 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: 10/27/2023
• Initial Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2014
• 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