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); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has concluded that lower and higher than expected vitros hba1c reagent lot: 1519-46-3073 results were obtained from two different levels of non-vitros biorad liquichek diabetes lot: 89290 controls on a vitros xt 7600 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.Historic quality control results obtained from vitros hba1c reagent lot: 1519-46-3073 showed some imprecision, therefore, a reagent related performance issue cannot be ruled out as contributing to the event.Acceptable performance was obtained using two alternate lots with the same qc fluids.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic performance issue with vitros reagent lot: 1519-46-3073.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower and higher than expected vitros hba1c reagent lot: 1519-46-3073 results were obtained from two different levels of non-vitros biorad liquichek diabetes lot: 89290 controls on a vitros xt 7600 system.Biorad level 1 vitros hba1c results of 6.30, 6.35 and 6.32 % ngsp vs.The baseline mean of 5.24 % ngsp.Biorad level 2 vitros hba1c results of 7.30, 9.95, 10.02, 9.95, 7.22, 7.20, 7.10, 7.10, 7.10, 7.02, 10.44 and 10,51 % ngsp vs.The baseline mean of 8.39 % ngsp.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The higher-than-expected vitros hba1c results were obtained from non-patient quality control fluids.There was no allegation of patient harm as a result of this event.This report is number three of six mdrs for this event.Six 3500a forms are being submitted for this event as six devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number: (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: 23809922
• Report Number: 1319808-2025-00038
• Device Sequence Number: 15777174
• Product Code: PDJ
• UDI-Device Identifier: 10758750030729
• UDI-Public: (01)10758750030729(17)260802(11)240802(10)463073
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/15/2025

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: 08/02/2026
• Device Catalogue Number: 6842905
• Device Lot Number: 2535-46-3073
• 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: 11/20/2025
• Initial Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2024
• 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