MAUDE Adverse Event Report: Ortho-Clinical Diagnostics, Inc. VITROS Immunodiagnostic Products CK-MB Reagent Pack; In-Vitro Diagnostics

Catalog Number	1896836
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2026
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 obtained from three patient samples tested using vitros immunodiagnostic products ck-mb reagent lot 4010 on a vitros xt 7600 integrated system when compared to results from the same samples tested using vitros ckmb reagent lot 3980.Correlation sample 1 vitros ckmb result of 2.31 ng/ml vs.The expected result of 4.98 ng/ml.Correlation sample 2 vitros ckmb result of 3.35 ng/ml vs.The expected result of 5.29 ng/ml.Correlation sample 6 vitros ckmb result of 2.34 ng/ml vs.The expected result of 5.29 ng/ml.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The lower than expected vitros ckmb results were not reported from the laboratory as they were generated during a lot to lot correlation.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 615283.
Additional Manufacturer Narrative
The investigation has determined that lower than expected vitros ckmb results were obtained from three patient samples tested using vitros immunodiagnostic products ck-mb reagent lot 4010 on a vitros xt 7600 integrated system when compared to results from the same samples tested using vitros ckmb reagent lot 3980.The assignable cause of the event is unknown with the information provided.The patient samples were not tested concurrently on both reagent lot 3980 and lot 4010.Only historical results from lot 3980 were used for comparison.The date the samples were collected and tested with reagent lot 3980 was not provided.The patient samples were preserved at 2-8 degrees c prior to testing.Per the vitros ckmb instructions for use, serum and plasma samples may be stored for up to 5 days at 2-8 degrees c (36-46 degrees f) or 4 weeks at -20 degrees c (-4 degrees f).The customer believed the samples may have been stored greater than 5 days at 2-8 degrees c, and that improper sample storage was a likely cause of the event.Historical quality control results generated within the timeframe of the event indicated that vitros ckmb reagent lot 4010 was performing as intended and did not likely contribute to the event.The customer made no allegation that there was issue with the performance of the vitros xt7600 integrated system, however, since no diagnostic within-run precision testing was performed within the timeframe of the event, an instrument related performance issue cannot be ruled out as contributing to the event.

• 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 ; +1(585)453-4165
• MDR Report Key: 50055653
• Report Number: 3007111389-2026-00127
• Device Sequence Number: 9490743
• Product Code: JHX
• UDI-Device Identifier: 10758750000203
• UDI-Public: (01)10758750000203(17)261215(11)260220(10)4010
• 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): 07/24/2026

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 Catalogue Number: 1896836
• Device Lot Number: 4010
• 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: 07/03/2026
• Initial Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2026
• 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