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

Catalog Number	6801710
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that lower than expected results were obtained from two different levels of non-vitros biorad immunoassay plus quality control (qc) fluids using the vitros valproic acid (valp) reagent lot 2511-37-3554 processed on a vitros 4600 chemistry system.The assignable cause of the lower than expected results is unknown.Vitros valp qc results were within expectation prior to both events, indicating that an issue with vitros valp lot 2511-37-3554 was not a likely contributor to the event.No information was provided regarding the storage or handling of the qc fluid in use, therefore an issue isolated to the qc fluids cannot be confirmed or ruled out as a contributor to the event.The lower than expected results were obtained from two vitros valp lot 2511-37-3554 reagent packs, pack ids 5976 and 8373.As the customer obtained acceptable results using vitros valp reagent pack ids 5976 and 8373 before and/or after the events, an issue with the reagent packs in use is not a likely contributor to the event.No diagnostic precision testing was performed on the vitros 4600 system at the time of the events, therefore a transient instrument issue can not be ruled out as a contributor to the event.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected results were obtained from two different levels of non-vitros biorad immunoassay plus quality control (qc) fluids using the vitros valproic acid (valp) reagent lot 2511-37-3554 processed on a vitros 4600 chemistry system.Vitros valp biorad level 1 results of <10, <10 ug/ml versus the expected result of 42 ug/ml vitros valp biorad level 3 results of <10, <10 ug/ml versus the expected result of 122 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-than-expected vitros valp results were obtained using qc fluids.There were no allegations of harm associated with this event.This report is number two 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 (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: nancy hewitson ; 100 indigo creek drive; rochester, NY 14626 ; 5854534165
• MDR Report Key: 25319780
• Report Number: 1319808-2026-00027
• Device Sequence Number: 12104559
• Product Code: LEG
• UDI-Device Identifier: 10758750006748
• UDI-Public: (01)10758750006748(17)270227(11)250827(10)373554
• 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): 05/28/2026

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 Catalogue Number: 6801710
• Device Lot Number: 2511-37-3554
• 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: 04/30/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2025
• 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