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

Catalog Number	8150112
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has determined that higher than expected lactate results were obtained from college of american pathologists (cap) proficiency samples using vitros chemistry products lactate (lac) slides lot 3533-0125-2686 on a vitros 5600 integrated system.The assignable cause of the events is unknown.Historical quality control for vitros lac lot 3533-0125-2686 displayed acceptable accuracy when compared to the biorad target values, and precision was also acceptable.Additionally, continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros lac reagent lot 3533-0125-2686.Precision testing was not performed on the vitros 5600 integrated system, therefore an instrument related issue cannot be fully ruled out as a contributor to the event.However, historical qc data was accurate compared to the biorad target values and showed acceptable precision, and there was no evidence of an instrument malfunction.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected lactate results were obtained from college of american pathologists (cap) proficiency samples using vitros chemistry products lactate (lac) slides lot 3533-0125-2686 on a vitros 5600 integrated system.Cap sample chm-12 results of 5.37 and 5.25 mmol/l vs an expected result of 4.52 mmol/l cap sample chm-14 result of 4.5 mmol/l vs an expected result of 3.87 mmol/l 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 vitros lac results were obtained from proficiency samples and no results were reported from the laboratory.There was no allegation of patient harm as a result of this event.This report is number one of three mdrs for this event.Three 3500a forms are being submitted for this event as three 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 LAC SLIDES
• 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.; 513 technology boulevard; rochester NY 14626
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 21473112
• Report Number: 1319809-2025-00020
• Device Sequence Number: 8840605
• Product Code: KHP
• UDI-Device Identifier: 10758750004454
• UDI-Public: (01)10758750004454(17)251101(11)240515(10)353301252686
• 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): 02/26/2025

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: 11/01/2025
• Device Catalogue Number: 8150112
• Device Lot Number: 3533-0125-2686
• 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: 01/30/2025
• Initial Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2024
• 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