MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK; IN-VITRO DIAGNOSTICS

Catalog Number	1896836
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has determined that a non-reproducible, higher than expected ck-mb result was obtained from a single patient sample processed using vitros immunodiagnostic products ck-mb reagent lot 3980 on a vitros 5600 integrated system.A definitive assignable cause could not be determined with the information provided.Based on historical quality control results, a vitros ck-mb reagent lot 3980 performance issue cannot be ruled out as a contributor of the event.Precision testing was not performed on the vitros 5600 integrated system to verify performance upon request.Therefore, an instrument related issue cannot be entirely ruled out as a contributor of the event.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 manufacturers 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.Additionally, as e-connectivity data was not able to be reviewed for the customer site, a preanalytical sample mix-up could not be confirmed or ruled out as a cause of the event.Continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros ck-mb reagent lot 3980.
Event or Problem Description
A field application specialist (fas), on behalf of a customer, contacted the ortho clinical diagnostics (ortho) technical solutions center (tsc) to report a non-reproducible, higher than expected ck-mb result obtained from a single patient sample processed using vitros immunodiagnostic products ck-mb reagent lot 3980 on a vitros 5600 integrated system.Patient sample result of 100.0 ng/ml vs.The expected result of 0.42 ng/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The non-reproducible, higher than expected vitros ck-mb result was not reported from the laboratory.There have been no 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).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK
• 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; felindre meadows; pencoed; bridgend CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: nancy hewitson ; 100 indigo creek drive; rochester, NY 14626 ; 5854534165
• MDR Report Key: 24895705
• Report Number: 3007111389-2026-00075
• Device Sequence Number: 15796860
• Product Code: JHX
• UDI-Device Identifier: 10758750000203
• UDI-Public: (01)10758750000203(17)260922(11)251125(10)3980
• 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): 04/16/2026

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 Expiration Date: 09/22/2026
• Device Catalogue Number: 1896836
• Device Lot Number: 3980
• 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: 03/30/2026
• Initial Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2025
• 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