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	05/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a lower-than-expected vitros sodium (na+) result was obtained from a single level of non-vitros biorad lot 56740 control using vitros na+ slide lot 4234-1120-5575 on a vitros 350 chemistry system.Biorad multiqual lot 56740 level 3 result of 141.0 mmol/l versus the expected result of 162.2 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+ result was obtained from a non-patient quality control fluid.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).
Additional Manufacturer Narrative
The investigation determined that a lower than expected vitros sodium (na+) result was obtained from a single level of non-vitros biorad lot 56740 control using vitros na+ slide lot 4234-1120-5575 on a vitros 350 chemistry system.The assignable cause of the lower than expected biorad level 1 control results was an instrument related performance issue.The results of a diagnostic within-run precision test performed by the customer used to assess instrument performance were outside of acceptable guidelines, indicating the vitros 350 chemistry system was not performing as intended.An ortho field engineer (fe) repeated the vitros na+ precision testing, along with a vitros potassium (k+) precision test prior to performing any service actions and both were within ortho acceptable guidelines.However, as imprecision can be intermittent, the ortho fe suspected the electrolyte reference fluid (erf) pump was the source of the imprecision observed by the customer and performed the service actions of replacing the erf and adjusted the erf metering and reservoir alignment.Post service diagnostic vitros na+ and k+ within-run precision testing was within ortho acceptance guidelines, indicating the vitros 350 chemistry system was returned to intended performance.

• 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: 19575361
• Report Number: 1319681-2024-00036
• Device Sequence Number: 18273981
• Product Code: JJE
• UDI-Device Identifier: 10758750002054
• UDI-Public: 10758750002054
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 06/18/2024

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: 05/24/2024
• Initial Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2012
• 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