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

Catalog Number	8221384
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has determined that a higher than expected phenobarbital (phbr) result was obtained from a non-vitros biorad level 1 quality control fluid using vitros chemistry products phbr slides lot 2511-0107-8274 on a vitros xt 7600 integrated system.The assignable cause for the higher than expected vitros phbr quality control result is unknown.An issue with the non-vitros biorad control fluid cannot be ruled out as a contributor to the event.The customer processed qc fluids three times on (b)(6) 2024, the day that the event occurred, and it was unable to be confirmed if the fluid was left out between runs.Historical vitros phbr was not running as expected, however the current performance of the vitros phbr assay is acceptable, indicating that an issue with vitros phbr lot 2511-0107-8274 is not a likely contributor to the event.No precision testing was performed on the vitros xt 7600 integrated system, however there was no indication that the system malfunctioned.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros phbr reagent lot 2511-0107-8274.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a higher than expected phenobarbital (phbr) result was obtained from a non-vitros biorad level 1 quality control fluid using vitros chemistry products phbr slides lot 2511-0107-8274 on a vitros xt 7600 integrated system.Vitros phbr biorad level 1 lot 85360 result of 13.56 ug/ml versus the expected result of 10.55 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 quality control fluid and no results were reported from the laboratory.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 PHBR SLIDES
• 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.; 513 technology boulevard; rochester NY 14626
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 20149962
• Report Number: 1319809-2024-00070
• Device Sequence Number: 20908271
• Product Code: DLZ
• UDI-Device Identifier: 10758750004560
• UDI-Public: (01)10758750004560(17)241201(11)231229(10)251101078274
• 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): 09/03/2024

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: 12/01/2024
• Device Catalogue Number: 8221384
• Device Lot Number: 2511-0107-8274
• 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: 08/10/2024
• Initial Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/29/2023
• 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