MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; IN-VITRO DIAGNOSTICS

Catalog Number	6801042
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report negatively biased vitros myoglobin (myog) results obtained from non-vitros biorad lot 1003110 level 1 quality control fluid using vitros immunodiagnostics products myog reagent lot 2670, on a vitros xt7600 integrated system.Biorad lot 1003110 l1 vitros myog results of 110.9, 110.6 and 113.0 ng/ml vs.The expected vitros myog value of 130 ng/ml.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 obtained from non-patient quality control fluids.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).
Additional Manufacturer Narrative
The investigation determined that negatively biased vitros myog results were obtained from non-vitros biorad lot 1003110 level 1 quality control fluid using vitros immunodiagnostics products myog reagent lot 2670, on a vitros xt7600 integrated system.The definitive assignable cause could not be determined with the information provided.Quality control results obtained using the biorad controls determined that intermittent acceptable and unacceptable performance was obtained within the timeframe of the event.Therefore, a reagent related performance issue cannot be ruled out as contributing to the event.In addition, the reagent pack in use generated an expired on-board stability code, indicating the customer was not following ortho specifications for reagent pack handling.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic performance issue with vitros myog reagent lot 2670.No information was provided concerning the sample handling of the biorad controls.In addition, there were four other assays having issue with the biorad qc performance.Therefore, inconsistent pre-analytical sample handling cannot be ruled out as contributing to the event.A performance issue with the vitros xt7600 integrated system could not be ruled out as a potential contributor to the event as there was no diagnostic within-run precision testing performed to assess the performance of the vitros xt7600 integrated system.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK
• Common Device Name: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; felindre meadows; pencoed; bridgend CF35 5PZ; UK CF35 5PZ
• 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: 24581750
• Report Number: 3007111389-2026-00045
• Device Sequence Number: 15761313
• Product Code: DDR
• UDI-Device Identifier: 10758750001019
• UDI-Public: (01)10758750001019(17)261020(13)251106(10)2670
• 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): 03/12/2026

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: 6801042
• Device Lot Number: 2670
• 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: 02/18/2026
• Initial Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2025
• 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