MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS HBA1C REAGENT; IN-VITRO DIAGNOSTICS

Catalog Number	6842905
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	01/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that a non-reproducible, higher than expected vitros hba1c result was obtained from a single patient sample using vitros chemistry products hba1c reagent lot 1539-42-2750 on a vitros xt7600 integrated system.The assignable cause of the event could not be determined.Diagnostic vitros gent within-run precision testing to assess instrument performance was not processed, therefore, an analyzer performance issue cannot be ruled out as contributing to the event.A review of historical quality control results indicated vitros hba1c reagent lot 1539-42-2750 was not performing as intended within the timeframe of the event and therefore, a reagent related performance issue at the customer site cannot be ruled out as contributing to the event.A complaint review found no additional complaints for vitros hba1c reagent lot 1539-42-2750.In addition, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic performance issue with vitros hba1c reagent lot 1539-42-2750.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic performance issue with vitros hba1c reagent lot 1539-42-2750.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a non-reproducible, higher than expected vitros hba1c result was obtained from a single patient sample using vitros chemistry products hba1c reagent lot 1539-42-2750 on a vitros xt7600 integrated system.Patient sample vitros hba1c result of 11.13 % ngsp vs.The expected result of 7.02 % ngsp 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 hba1c result was not reported outside of 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 HBA1C REAGENT
• 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.; 1000 lee road; rochester NY 14606
• Manufacturer Contact: nancy hewitson ; 100 indigo creek drive; rochester, NY 14626 ; 5854534165
• MDR Report Key: 24280823
• Report Number: 1319808-2026-00005
• Device Sequence Number: 8318974
• Product Code: PDJ
• UDI-Device Identifier: 10758750030729
• UDI-Public: (01)10758750030729(17)260209(11)240209(10)422750
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 02/05/2026

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: 02/09/2026
• Device Catalogue Number: 6842905
• Device Lot Number: 1539-42-2750
• 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: 01/12/2026
• Initial Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2024
• 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