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

Catalog Number	6801710
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that lower and higher than expected valproic acid (valp) results were obtained from non-vitros biorad quality control (qc) fluids processed using vitros chemistry products valp reagent lot 2511-34-2390 on a vitros xt 7600 integrated system.The assignable cause of the event is unknown.Based on historical qc results, a vitros valp reagent lot 2511-34-2390 related issue could not be ruled out as a contributor to the event.The review identified within-lab imprecision; however, the magnitude of the observed imprecision is significantly less than that of the data point excursions that breached phs criteria for the vitros valp assay.In addition, an issue isolated to any individual pack was ruled out as a review of econn data identified imprecise results across four different vitros valp packs.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros valp reagent lot 2511-34-2390.The tsc confirmed that the customer was following biorad manufacturer recommendations for qc sample handling, therefore a qc fluid handling issue is not a likely contributor to the event.Pre-service precisions studies passed, indicating that the vitros valp reagent and the vitros xt 7600 integrated system were both performing as intended prior to service actions on 05 september 2024.For this reason, the vitros xt 7600 integrated system was not a likely contributor to the issue.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower and higher than expected valproic acid (valp) results were obtained from non-vitros biorad quality control (qc) fluids processed using vitros chemistry products valp reagent lot 2511-34-2390 on a vitros xt 7600 integrated system.Biorad lot 85340 level 1: 25.70, 24.52, 51.33 ug/ml vs an expected result of 35.88 ug/ml biorad lot 85340 level 2: 61.97, 62.30, 62.15, 61.68, 62.70 ug/ml vs an expected result of 78.41 ug/ml biorad lot 85340 level 3: 90.73, 90.69 ug/ml vs an expected result of 113.56 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 and higher than expected results were from a quality control fluid and were not reported outside of the laboratory.Due to the low volume of valp patient testing at this customer site, it is unknown whether or not patient results have been impacted by this issue.However, it has been confirmed that there have been no reported issues from the physicians and no allegations of patient harm as a result of this event.This report is number one of two mdrs for this event.Two 3500a forms are being submitted for this event as two devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment 607522.

• 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: 20339194
• Report Number: 1319808-2024-00036
• Device Sequence Number: 8054931
• Product Code: LEG
• UDI-Device Identifier: 10758750006748
• UDI-Public: (01)10758750006748(17)250911(11)240311(10)342390
• 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): 09/30/2024

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: 09/11/2025
• Device Catalogue Number: 6801710
• Device Lot Number: 2511-34-2390
• 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: 09/03/2024
• Initial Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2024
• 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