MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS VANC REAGENT; IN-VITRO DIAGNOSTICS

Model Number	6801709
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that a higher than expected vitros vancomycin (vanc) result was obtained from a single patient sample processed using vitros chemistry products vanc reagent lot 2514-51-1301 on a vitros xt 7600 integrated system.The assignable cause of the event is a sample related issue.The customer stated that the initial patient sample had been erroneously collected through a centralized catheter through which the patient receives tpn (parenteral nutrition through central catheter).The customer also stated that the physician has advised collection staff not to draw blood in this way.The customer stated that the initial sample appeared to be lipemic.Additionally, the hit values for the initial sample were higher than expected, especially the turbidity values.The customer was only able to obtain a result for the initial sample after a dilution was applied as when it was processed undiluted, no results were obtained and the analyzer posted multiple condition codes.An expected result for the patient was obtained from a redraw sample.Historical vitros vanc qc results obtained prior to the event and results obtained after the event were within expectations indicating that an issue related to the performance of the vanc reagent or the vitros xt 7600 system was not likely a contributing factor of the event.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros vanc lot 2514-51-1301.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a higher than expected vitros vancomycin (vanc) result was obtained from a single patient sample processed using vitros chemistry products vanc reagent lot 2514-51-1301 on a vitros xt 7600 integrated system.Patient sample result of 103.04 mg/l (ug/ml) vs an expected result of 37.24 mg/l (ug/ml) biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The higher than expected result was reported out of the laboratory, however, a physician questioned the result and no treatment was initiated, altered or stopped based on the result.A redraw sample was obtained from the patient and a corrected result report was later issued.Ortho has not been made aware of any 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 CHEMISTRY PRODUCTS VANC REAGENT
• Common Device Name: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS, INC.; 1000 lee road; rochester NY 14606
• Manufacturer Contact: laurie o'riordan ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 17208218
• Report Number: 0001319808-2023-00012
• Device Sequence Number: 14895024
• Product Code: LEH
• UDI-Device Identifier: 10758750006731
• UDI-Public: 10758750006731
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• Number of Events Summarized: 1
• Summary Report (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): 06/26/2023

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 Expiration Date: 10/01/2023
• Device Model Number: 6801709
• Device Catalogue Number: 6801709
• Device Lot Number: 2514-51-1301
• 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: 05/30/2023
• Initial Report FDA Received Date: 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• 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