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	02/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that a higher than expected valproic acid (valp) result was obtained from a vitros therapeutic drug monitoring performance verifier (tdm pv) fluid using vitros chemistry products valp reagent lot 2511-32-1764 on a vitros xt 7600 integrated system.The assignable cause of the event is unknown.Historical vitros valp quality control was within expectation, indicating that an issue with vitros valp lot 2511-32-1764 is not a likely contributor to the event.No precision testing was processed on the vitros xt 7600 system at the time of the event or this report.Therefore, an instrument issue cannot be confirmed or ruled out as a contributor to the event.The customer was unfamiliar with basic software features and maintenance/ adjustments.An ortho field application specialist is scheduled to go the customer site to perform additional training for the staff.It is possible that a protocol issue contributed to the event, although this could not be confirmed.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros valp lot 2511-32-1764.
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 performance verifier (tdm pv) fluid using vitros chemistry products valp reagent lot 2511-32-1764 on a vitros xt 7600 integrated system.Vitros valp tdm pv i lot v1171 result of 37.2 versus the expected result of 25.05 (customers baseline mean) 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 quality control fluid and was not reported outside of the laboratory.The customer confirmed that patient samples were not processed during the timeframe of the event.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 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: 18893769
• Report Number: 1319808-2024-00007
• Device Sequence Number: 12627247
• Product Code: LEG
• UDI-Device Identifier: 10758750006748
• UDI-Public: 10758750006748
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/12/2024

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: 12/30/2024
• Device Catalogue Number: 6801710
• Device Lot Number: 2511-32-1764
• 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: 02/15/2024
• Initial Report FDA Received Date: 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown