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

Catalog Number	6802153
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has determined that lower than expected potassium (k+) results were obtained from a vitros performance verifier (pv) using vitros chemistry products k+ slides lot 4102-1138-1818 on a vitros 350 chemistry system.The assignable cause of the event is an instrument related issue.The results from a vitros k+ diagnostic precision test processed on the vitros 350 chemistry system were not within expectations.In addition, quality control results for vitros k+ were not acceptable on the date of the event.An ortho field engineer performed service actions on the instrument which included replacing the electrometer.The results from post service vitros k+ diagnostic precision tests performed on the instrument were within expectations.Additionally, there has been no reported recurrence from the customer of unacceptable vitros k+ results since the event.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected potassium (k+) results were obtained from a vitros performance verifier (pv) using vitros chemistry products k+ slides lot 4102-1138-1818 on a vitros 350 chemistry system.Vitros pv ii lot n9816 results of 3.02 and 3.27 mmol/l vs the expected result of 5.59 mmol/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 lower than expected vitros k+ results were obtained from a quality control fluid and were not reported from the laboratory.However, the investigation cannot conclude that patient sample results were not or would not be affected if the event were to recur undetected.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).

• 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 ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 19705548
• Report Number: 1319681-2024-00040
• Device Sequence Number: 11687772
• Product Code: JJE
• UDI-Device Identifier: 10758750002054
• UDI-Public: (01)10758750002054
• 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): 07/09/2024

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: 06/13/2024
• Initial Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2015
• 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