MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 9; IN-VITRO DIAGNOSTICS

Catalog Number	8568040
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that a lower than expected vitros phyt result was obtained from a single non-vitros biorad lot 45960 level 3 quality control fluid using vitros phyt slide lot 2626-0186-4395 on a vitros xt7600 integrated system.The most likely assignable cause was the calibration in use when the event occurred.Although the calibration responses and parameters appeared typical to expected responses and parameters, a quality control review indicates the accuracy issue was isolated to the calibration curve in use at the time of the event.Acceptable performance was obtained from the same slide lot using an alternate calibration event using an alternate lot of calibrators.It is unlikely calibration kit 0942 was the cause of the event as acceptable performance was obtained on an alternate vitros xt7600 integrated system on site from calibrations obtained using calibrator kit lot 0942.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros phyt slide lot 2626-0186-4395.The vitros xt7600 integrated system did not likely contribute to the event as a diagnostic vitros crbm within-run precision test, used to assess the performance of the immunorate subsystem of the vitros xt7600 integrated system was acceptable, indicating the vitros xt7600 integrated system did not malfunction.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a lower than expected vitros phyt result was obtained from a single non-vitros biorad lot 45960 level 3 quality control fluid using vitros phyt slide lot 2626-0186-4395 on a vitros xt7600 integrated system.Biorad lot 45960 level 3 vitros phyt result of 13.7 ug/ml versus the expected result of 17.12 ug/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 lower than expected result was obtained from a non-patient quality control fluid.There were no allegations of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) (b)(4) and reportability assessment (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 9
• 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: 18131865
• Report Number: 0001319808-2023-00017
• Device Sequence Number: 7753249
• Product Code: JIT
• UDI-Device Identifier: 10758750005031
• UDI-Public: 10758750005031
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/14/2023

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: 06/06/2024
• Device Catalogue Number: 8568040
• Device Lot Number: 0942
• 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: 10/17/2023
• Initial Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2022
• 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