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

Catalog Number	6801710
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a higher than expected valproic acid (valp) result was obtained from a vitros therapeutic drug monitoring (tdm) performance verifier processed using vitros chemistry products valp reagent lot 2511-33-2028 on a vitros xt 7600 integrated system.Vitros tdm i lot y1734 result of 39.0 ug/ml vs an expected result of 27.6 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 result was from a non-patient fluid and was not reported outside of the laboratory.The customer did not confirm when requested whether patient sample results were affected or questioned.There was no reported 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).
Additional Manufacturer Narrative
The investigation determined that a higher than expected valproic acid (valp) result was obtained from a vitros therapeutic drug monitoring (tdm) performance verifier processed using vitros chemistry products valp reagent lot 2511-33-2028 on a vitros xt 7600 integrated system.The investigation was unable to determine a definitive assignable cause.Based on historical qc results a vitros valp reagent lot 2511-33-2028 related issue is not a likely contributor to the event.Additionally, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros valp reagent lot 2511-33-2028.As precision testing was not performed on the vitros xt 7600 system, an instrument related issue cannot be ruled out as a contributing factor of the event.However, there was no evidence suggesting that the vitros xt 7600 system malfunctioned.In addition, as no details of the customers initial protocol when preparing and handling the vitros tdm fluids was provided, an issue related to improper protocol cannot be completely ruled out as a contributing factor of the event.The customer reprocessed the same vials of vitros tdm fluids and obtained expected results.Therefore, an issue related the vitros tdm fluid is not a likely contributor of the event.However, prior to testing, the customer had recalibrated vitros valp lot 2511-33-2028 using a fresh reagent pack.Therefore, a suboptimal calibration from 26 may 2024 or a reagent pack related issue cannot be ruled out as contributors of the event.

• Brand Name: VITROS CHEMISTRY PRODUCTS VALP 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 ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 19600583
• Report Number: 1319808-2024-00016
• Device Sequence Number: 8205073
• Product Code: LEG
• UDI-Device Identifier: 10758750006748
• UDI-Public: (01)10758750006748(17)250503(11)231103(10)332028
• 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): 06/24/2024

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: 05/03/2025
• Device Catalogue Number: 6801710
• Device Lot Number: 2511-33-2028
• 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: 05/26/2024
• Initial Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2023
• 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