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

Catalog Number	6802153
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected vitros ammonia (amon) results were obtained from vitros liquid performance verifiers (lpv) and non-vitros biorad quality control fluids processed using vitros chemistry products amon slides lot 1020-0262-4671 on a vitros 350 chemistry system.Vitros lpv i lot d1516 results of 115.0, 213.0 and 118.0 umol/l versus an expected result of 42.6 umol/l vitros lpv ii lot e1517 results of 308.0 and 255.0 umol/l versus an expected result of 191.9 umol/l biorad lot 54410 level 1 results of 217.8, 112.2 and 103.0 umol/l versus an expected result of 31.24 umol/l biorad lot 54410 level 2 results of 171.9, 117.8 and 189.9 umol/l versus an expected result of 93.03 umol/l biorad lot 54410 level 3 results of 362.4, 398.7, 307.3, 283.7, 384.6 and 292.8 umol/l versus an expected result of 233.63 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 when processing control fluids.No results were reported out of the laboratory.There have been 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).
Additional Manufacturer Narrative
The investigation determined that higher than expected vitros ammonia (amon) results were obtained from vitros liquid performance verifiers (lpv) and non-vitros biorad quality control fluids processed using vitros chemistry products amon slides lot 1020-0262-4671 on a vitros 350 chemistry system.The assignable cause of the higher than expected vitros amon results is an instrument issue related to microslide incubator contamination.The results from vitros lpv fluids were not within expectations.Additionally, historical biorad qc results were imprecise.The customer performed maintenance actions on the vitros 350 system which included cleaning the microslide incubator and replacing the cm/rt evaporation caps.Following maintenance actions, the results of a vitros amon within run precision test were within ortho acceptable guidelines.

• Brand Name: VITROS 350 CHEMISTRY SYSTEM
• Common Device Name: CHEMISTRY ANANLYZER
• 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: 18503469
• Report Number: 0001319681-2024-00004
• Device Sequence Number: 12737944
• Product Code: JJE
• UDI-Device Identifier: 10758750002054
• UDI-Public: 10758750002054
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 01/10/2024

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: 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: 12/18/2023
• Initial Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2013
• 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