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	06/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that higher and lower than expected vitros ammonia (amon) results were obtained from non-vitros mas quality control fluids and a vitros liquid performance verifier (lpv) processed using vitros chemistry products amon slides lot 1020-0265-7076 on a vitros 4600 chemistry system.The assignable cause of the event is an instrument issue likely related to microslide incubator contamination.A calibration and quality control results for the vitros amon reagent were not within expectations.The customer was advised to complete the microslide incubator decontamination procedure on the vitros 4600 system, replace the cm/rt evaporation caps and to perform post maintenance within run precision testing in order to verify the instrument performance.The customer is processing samples for vitros amon on the alternate vitros instrument at the site using vitros amon reagent lot 1020-0265-7076 without issue.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher and lower than expected vitros ammonia (amon) results were obtained from non-vitros mas quality control fluids and a vitros liquid performance verifier (lpv) processed using vitros chemistry products amon slides lot 1020-0265-7076 on a vitros 4600 chemistry system.Mas alcohol/ammonia control lot 2409 level 1 vitros amon result of 292.2 umol/l versus an expected result of 25.0 umol/l mas alcohol/ammonia control lot 2409 level 2 vitros amon results of 117.7, 114.8, 102.3, 37.6, 111.2, 110.3, 76.8, 113.0, 102.0, 114.4, 92.4, 114.5, 115.1 and 114.9 umol/l versus an expected result of 148.3 umol/l vitros lpv ii lot t8395 result of 153.1 umol/l vs an expected result of 203.4 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 and lower than expected vitros amon results were obtained when processing control fluids.The customer stated that patient results have not been affected as samples were being processed for vitros amon on an alternate vitros instrument at the site.There were no reported allegations 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 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 ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 20441026
• Report Number: 1319681-2024-00055
• Device Sequence Number: 12831000
• Product Code: JJE
• UDI-Device Identifier: 10758750012343
• UDI-Public: (01)10758750012343
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 10/11/2024

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: 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: 09/17/2024
• Initial Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2013
• 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