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

Model Number	6801710
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a lower than expected valproic acid (valp) result was obtained from a patient sample processed during a reagent lot to lot correlation using vitros chemistry products valp reagent lot 2511-31-9784 on a vitros 5600 integrated system.Patient 2 sample result of 35.95 ug/ml vs an expected result of 49.64 ug/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The lower than expected result was from a patient sample that was processed during reagent lot to lot correlation testing and was not reported outside of the laboratory.No erroneous patient sample results were reported from the laboratory.At the time of this report, the customer has elected to send patient samples to an alternate site for valp testing until troubleshooting is complete.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).
Additional Manufacturer Narrative
The investigation determined that a lower than expected valproic acid (valp) result was obtained from a patient sample processed during a reagent lot to lot correlation using vitros chemistry products valp reagent lot 2511-31-9784 on a vitros 5600 integrated system.The investigation was unable to determine a definitive assignable cause.Quality control results using biorad controls and vitros tdm pv fluids were within expectations for vitros valp lot 2511-31-9784 on the date of the event.Additionally, historical qc results for the customer¿s previous vitros valp reagent lot were accurate and precise in combination with the vitros 5600 integrated system indicating that a reagent or instrument related issue are not likely contributing factors of the event.A reagent pack related issue is not a likely contributing factor of the event as acceptable qc results were obtained on the same reagent pack in which the lower than expected patient sample results were obtained.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros valp reagent lot 2511-31-9784.

• 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 ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 17226166
• Report Number: 0001319808-2023-00014
• Device Sequence Number: 12564493
• Product Code: LEG
• UDI-Device Identifier: 10758750006748
• UDI-Public: 10758750006748
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/28/2023

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: 11/06/2023
• Device Model Number: 6801710
• Device Catalogue Number: 6801710
• Device Lot Number: 2511-31-9784
• 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: 06/06/2023
• Initial Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2022
• 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