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	09/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation concluded that lower and higher than expected results were obtained from two different levels of non-vitros biorad ethanol/ammonia controls, lot 54390, using vitros ammonia (amon) slide lots 1019-0266-5803 and slide lot 1020-0265-0764 on a vitros 4600 chemistry system.The assignable cause of the event for the results obtained prior to the service actions was determined to be an instrument related issue likely due to the dirty cm/rt incubator evaporation caps.Vitros amon within run precision testing was unacceptable and atypical within-lab vitros amon qc performance was observed on both of the vitros amon slide lots.An ortho field engineer (fe) went on site and replaced the cm/rt incubator evaporation caps and cleaned the cm/rt incubator ring.Following those actions, acceptable within-run amon precision results were obtained indicating the vitros 4600 chemistry system was performing as expected.The assignable cause of the event for the results obtained after the service event (with the exception of data point 112.2 umol/l) was determined to be a suboptimal calibration (cal id 6429), demonstrated by the atypical calibration data and unacceptable post-calibration qc results.The cause of the suboptimal calibration is unknown.The assignable cause of the event that occurred during the post-service precision study (result of 112.2 ?mol/l) is unknown.Continual tracking and trending does not indicate a systemic issue with vitros amon side lot 1019-0266-5803.
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 non-vitros biorad ethanol/ammonia controls, lot 54390, using vitros ammonia (amon) slide lots 1019-0266-5803 and slide lot 1020-0265-0764 on a vitros 4600 chemistry system.Vitros amon reagent slide lot 1020-0265-0764: biorad level 2 amon results of 61.71, 63.51, 112.45, 68.28, 70.84, 68.46, and 62.67 ?mol/l vs.The expected result of 92.88 ?mol/l biorad level 3 amon results of 187.76 ?mol/l vs.The expected result of 239.90 ?mol/l vitros amon reagent slide lot 1019-0266-5803: biorad level 2 amon results of 122.83, 113.59, 72.81, and 59.75 ?mol/l vs.The expected result of 92.40 ?mol/l biorad level 3 amon results of 184.23 ?mol/l vs.The expected result of 242.10 ?mol/l liquid performance verifier ii amon results of 129.17, 142.36, 143.74, 145.21, 145.97, 148.40, 149.81, 150.95, 152.00, 152.40, 153.53 and 154.35 ?mol/l vs.The expected result of 194.70 ?mol/l after service interventions using vitros amon reagent slide lot 1019-0266-5803: biorad level 2 amon results of 115.40, 115.04, and 112.20 ?mol/l vs.The expected result of 92.40 ?mol/l biorad level 3 amon results of 299.53, 295.91, 295.97, 303.54, and 323.53? mol/l vs.The expected result of 242.10? 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 is number one of three mdrs for this event.Three 3500a forms are being submitted for this event as three devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint numbers (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: 20509233
• Report Number: 1319681-2024-00057
• Device Sequence Number: 9044228
• Product Code: JJE
• UDI-Device Identifier: 10758750012343
• UDI-Public: (01)10758750012343
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 10/22/2024

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: 09/25/2024
• Initial Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2018
• 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