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

Catalog Number	8058232
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a non-reproducible, lower than expected vitros ckmb result was obtained from a single patient sample processed using vitros chemistry products creatine kinase -mb (ckmb) slides lot 4924-0273-8928 on a vitros xt 3400 chemistry system.Patient sample vitros ckmb result of 3 u/l vs an expected result of 25 u/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The non-reproducible, lower than expected result was not reported from the laboratory.There have been no reported allegations 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 has determined that a non-reproducible, lower than expected vitros ckmb result was obtained from a single patient sample processed using vitros chemistry products creatine kinase -mb (ckmb) slides lot 4924-0273-8928 on a vitros xt 3400 chemistry system.Based on the limited information provided, a definitive assignable cause of the event was unable to be determined.As no quality control results were provided and the vitros system at the customer site is not e-connected, a vitros ckmb lot 4924-0273-8928 performance issue cannot be ruled out as a contributor of the event.The customer stated that vitros ckmb quality control results were within expectations indicating that a reagent related issue was not a likely contributing factor of the event.However, an individual slide related issue cannot be ruled out.As precision testing was not performed on the vitros xt 3400 chemistry system, an instrument related issue cannot be completely ruled out as a contributor of the event.However, there was no indication that the vitros xt 3400 system malfunctioned.Additionally, pre-analytical sample processing could not be ruled out as a contributing factor as it is unknown if the customer was following the sample collection device manufacturer recommended centrifugation protocol.Improper pre-analytical sample handling could have contributed to the event.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.Continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros ckmb lot 4924-0273-8928.

• Brand Name: VITROS CHEMISTRY PRODUCTS CKMB 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: 22371255
• Report Number: 1319809-2025-00056
• Device Sequence Number: 12768701
• Product Code: JHS
• UDI-Device Identifier: 10758750004294
• UDI-Public: (01)10758750004294(17)260601(11)241204(10)492402738928
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 06/25/2025

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: 06/01/2026
• Device Catalogue Number: 8058232
• Device Lot Number: 4924-0273-8928
• 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: 06/05/2025
• Initial Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2024
• 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