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

Catalog Number	6801709
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation confirmed that a non-reproducible, lower than expected vitros vancomycin (vanc) result was obtained when processing a patient sample on a vitros xt7600 system when compared with the repeat result.A definitive assignable cause could not be determined.Historical quality control results do not indicate an accuracy issue with vitros vanc lot 2514-53-1559 as a cause of the event.Diagnostic within run precision tests do not indicate an issue with the performance of vitros xt7600 system or vanc reagent lot 2514-53-1559 as a cause of the event.Although the historical quality control results and the diagnostic within run precision tests do not indicate an issue with either vitros vanc reagent lot 2514-53-1559 or the vitros xt7600 system an unexpected issue with the vitros xt7600 or an unknown reagent pack issue could not be entirely ruled out as the cause of the event.The customer is not following the collection device manufacturer¿s centrifugation recommendations when processing the patient sample.Therefore, a sample related issue may have contributed to the event.Ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros vanc lot 2514-53-1559.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a non-reproducible, lower than expected vitros vancomycin (vanc) result was obtained when processing a patient sample on a vitros xt7600 system when compared with the repeat result.Vitros vanc result of <5 ug/ml versus the repeat vitros vanc result of 25.4 ug/ml.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The lower than expected vitros vanc result was reported outside of the laboratory and a corrected report was later issued.There was no reported allegation 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 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: 18348079
• Report Number: 0001319808-2023-00019
• Device Sequence Number: 6268572
• Product Code: LEH
• UDI-Device Identifier: 10758750006731
• UDI-Public: 10758750006731
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 12/18/2023

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: 01/24/2024
• Device Catalogue Number: 6801709
• Device Lot Number: 2514-53-1559
• 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: 11/21/2023
• Initial Report FDA Received Date: 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2023
• 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