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

Catalog Number	8001133
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected vitros ckmb results were obtained from a vitros isoenzyme performance verifier (ipv) processed using vitros chemistry products ckmb slides lot 4922-0272-8370 on a vitros 350 chemistry system.Vitros ipv i lot y2755 vitros ckmb results of 9.3, 13.8, 11.1, 7.8, 12.7, 10.7, 12.1, 9.7, 10.6, 12.3, 6.3, 15.0, 11.1, 15.1, 8.7, 8.7 and 15.2 u/l vs an expected result of 21.5 u/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 lower-than-expected results were from a non-patient control fluid and were not reported from the laboratory.The customer stated that no patient sample results had been processed during the timeframe of the event.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).
Additional Manufacturer Narrative
The investigation has determined that lower than expected vitros ckmb results were obtained from a vitros isoenzyme performance verifier (ipv) processed using vitros chemistry products ckmb slides lot: 4922-0272-8370 on a vitros 350 chemistry system.The assignable cause of the event is user error as the customer was not using an appropriate pipette when reconstituting the vitros calibrator kit 6 vials and the vitros ipv fluids.Suboptimal calibrations were obtained by the customer using two different lots of vitros cal kit 6.The customer was using a serological pipette at the time of the event.According to the instructions for use (ifu) for both vitros cal kit 6 and the vitros ipv fluids: a class a volumetric pipette or an automated pipette of equivalent accuracy is recommended because of the importance of the reconstitution procedure to the accuracy of the results.An ortho field application specialist (fas) provided the customer with a volumetric pipette and assisted the customer with preparing fresh vials of vitros cal kit 6 lot: 0674 and the vitros ipv fluids.The customer, with assistance from the ortho fas, calibrated two different lots of vitros ckmb slides on the vitros 350 system and then processed the vitros ipv fluids post calibration.The results from both levels of vitros ipv fluids were within expectations for both lots of vitros ckmb slides.Additionally, the customer informed the ortho fas that the local distributor does not always maintain proper storage of vitros products during delivery.An issue related to product storage affecting the vitros products including the vitros ckmb reagent, vitros cal kit 6 and vitros ipv fluids in use at the customer site is a likely contributor 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 ckmb lot: 4922-0272-8370 or any of the vitros products in use at the customer site.

• 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: 24392383
• Report Number: 1319809-2026-00012
• Device Sequence Number: 10518842
• Product Code: JHS
• UDI-Device Identifier: 10758750004201
• UDI-Public: (01)10758750004201(17)260501(11)241118(10)492202728370
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 02/19/2026

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: 05/01/2026
• Device Catalogue Number: 8001133
• Device Lot Number: 4922-0272-8370
• 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: 01/22/2026
• Initial Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2024
• 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