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	02/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that lower than expected sodium (na+) results were obtained from a non-vitros biorad quality control fluid using vitros chemistry products na+ slides lot 4218-1101-9669 on a vitros 350 chemistry system.The assignable cause of the lower than expected vitros na+ results is suboptimal calibrations.The tsc reviewed the parameters for the calibration events that were in use when the lower than expected vitros na+ result were obtained and determined them to be atypical when compared to the database values.The cause of the suboptimal calibrations is user error, as the customer programmed the vitros 350 system to calibrate the assays using an incorrect vitros cal kit lot.Following recalibration events of the assays on the instrument with the correct vitros cal kit lot programmed, post calibration qc results returned to expectation.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected sodium (na+) results were obtained from a non-vitros biorad quality control fluid using vitros chemistry products na+ slides lot 4218-1101-9669 on a vitros 350 chemistry system.Vitros na+ biorad lot 92960 level 2 results of 141, 141, 144, and 143 mmol/l versus the expected result of 156 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 na+ results were obtained from a quality control fluid and no results were reported from the laboratory.There was no allegation 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: 18828325
• Report Number: 1319681-2024-00017
• Device Sequence Number: 7878912
• Product Code: JJE
• UDI-Device Identifier: 10758750002054
• UDI-Public: 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/28/2024

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: 02/05/2024
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2013
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown