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

Catalog Number	8568040
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that a higher than expected vitros phenobarbital (phbr) result was obtained from a single college of american pathologists (cap) proficiency survey sample when processed using vitros phbr slide lot 2511-0107-8229 on a vitros xt 7600 integrated system.The assignable cause of the event was a suboptimal calibration; however, the cause of the suboptimal calibration could not be determined.Calibration responses and parameters were atypical when compared to expected responses and parameters.In addition, the acceptable vitros phbr results obtained from three of the four cap samples were at the high end of the acceptable range, and historic quality control results obtained from one of two levels of vitros therapeutic drug monitoring performance verifier fluids were high outside the established vitros range of means.An instrument-related performance issue did not likely contribute to the event as acceptable vitros phbr performance was obtained using an alternate vitros phbr slide lot without performing any actions to optimize the vitros xt 7600 system.In addition, the results of diagnostic vitros crbm precision testing, used to assess instrument performance, were within acceptable guidelines.However, as the precision testing was not performed within the timeframe of the event, a transient issue with the vitros xt 7600 system cannot be entirely rule out as a contributor of the event.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros phbr slide lot 2511-0107-8229.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a higher than expected vitros phenobarbital (phbr) result was obtained from a single college of american pathologists (cap) proficiency survey sample when processed using vitros phbr slide lot 2511-0107-8229 on a vitros xt 7600 integrated system.Proficiency sample chm-05 result of 32.0 vs.The cap peer target 25.97 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 higher than expected vitros phbr result was obtained from a non-patient proficiency sample.No vitros phbr patient results have been questioned by the customer and 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).

• 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 ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 19617854
• Report Number: 1319808-2024-00017
• Device Sequence Number: 6963103
• Product Code: JIT
• UDI-Device Identifier: 10758750005031
• UDI-Public: (01)10758750005031(17)250117(11)230117(10)0952
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 06/25/2024

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 Expiration Date: 01/17/2025
• Device Catalogue Number: 8568040
• Device Lot Number: 0952
• 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: 05/30/2024
• Initial Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2023
• 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