MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS 5600 INTEGRATED SYSTEM-REFURBISHED; CHEMISTRY ANALYZER

Catalog Number	6802915
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has determined that higher than expected nt-probnp ii (ntbnp ii) results were obtained when processing a nonvitros biorad quality control (qc) fluid on a vitros 5600 integrated system.An assignable cause of the event was not determined.Based on the historical vitros ntbnp ii quality control results obtained, a reagent performance issue is not likely a contributor to the event.No information was provided with regards to how the qc samples were handled prior to processing, therefore, it is possible that improper preanalytical qc handling contributed to this event, however, this cannot be confirmed.It was confirmed that the customer does not perform routine maintenance of the analyzer as required.Failure to perform routine maintenance could affect vitros ntbnp ii results.No diagnostic precision testing was conducted to verify the performance of the vitros 5600 integrated system at the time of the event.In addition, an ortho field engineer (fe) has performed service actions at the customer site for other microwell assay issues and it is expected that the fe will return for continued service actions.Therefore, it is likely that an instrument related issue is a contributor to this event.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected nt-probnp ii (ntbnp ii) results were obtained when processing a nonvitros biorad quality control (qc) fluid on a vitros 5600 integrated system.Biorad level 1 results of 127.3, 155.5,227.3, 174.99 and 176.02 pg/ml vs expected result of 59.9 pg/ml 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 ntbnp ii results were obtained when processing non-vitros qc fluid.The customer made no indication that any patient sample results had been affected.There were no reported allegations of 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 5600 INTEGRATED SYSTEM-REFURBISHED
• 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 ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 17644843
• Report Number: 0001319681-2023-00045
• Device Sequence Number: 15448415
• Product Code: JJE
• UDI-Device Identifier: 10758750007110
• UDI-Public: 10758750007110
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 08/29/2023

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: 6802915
• 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: 08/02/2023
• Initial Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2011
• 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