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

Catalog Number	8001133
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that higher than expected vitros ckmb result was obtained from a single patient sample using vitros ckmb slide lot 4926-0279-3243 on a vitros xt3400 integrated system, when compared to results obtained using a non-vitros mass spectrometry result.The assignable cause of the event is unknown with the information provided.A vitros ckmb slide lot 4926-0279-3243 performance issue did not likely contribute to the event as historic quality control results were acceptable.In addition, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros ckmb slide lot 4926-0279-3243.No diagnostic within-run precision testing was performed to assess the performance of the vitros xt3400 integrated system, therefore, a performance issue with the vitros xt3400 integrated system could not be ruled out as contributing to the event.It is possible an unknown sample interferent that affects the vitros ckmb assay but not the non-vitros mass spectrometry assay was the cause of the event, however, no additional interference testing was performed so this could not be confirmed.The customer provided no information concerning sample processing or handling of the correlation samples.Therefore, pre-analytical sample processing could not be ruled out as a contributing factor, as it was not possible to establish if the customer was following the sample collection device manufactures recommendation for sample centrifugation and cellular debris, due to poor sample preparation, was potentially present in the affected sample, although this could not be confirmed.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected vitros ckmb result was obtained from a single patient sample using vitros ckmb slide lot 4926-0279-3243 on a vitros xt3400 integrated system, when compared to results obtained using a non-vitros mass spectrometry result.Patient sample vitros ckmb result of >1500 u/l vs.The non-vitros result of 4.8 u/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The higher-than-expected vitros ckmb result was not reported from the laboratory and 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).

• 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: nancy hewitson ; 100 indigo creek drive; rochester, NY 14626 ; 5854534165
• MDR Report Key: 24531044
• Report Number: 1319809-2026-00020
• Device Sequence Number: 8971994
• Product Code: JHS
• UDI-Device Identifier: 10758750004294
• UDI-Public: (01)10758750004294(17)261001(11)250418(01)492602793243
• 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): 03/05/2026

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: 10/01/2026
• Device Catalogue Number: 8001133
• Device Lot Number: 4926-0279-3243
• 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: 02/06/2026
• Initial Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2025
• 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