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

Catalog Number	6842905
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has concluded that lower than expected vitros hba1c reagent lot 2539-44-3184 results were obtained from two different levels of vitros %a1c performance verifier (pv) fluids on a vitros 5600 integrated system.The most likely assignable cause of the event was an unknown performance issue with vitros hba1c reagent lot 2539-44-3184, pack id 427.All of the vitros hba1c results that met potential health and safety criteria were generated using vitros hba1c reagent lot 2539-44-3184 pack id 427.A quality control review indicates acceptable performance was obtained using vitros hba1c reagent lot 2539-44-3184 prior to pack id 427 being used.The cause of the performance issue with pack id 427 could not be determined.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic performance issue with vitros reagent lot 2539-44-3184.No diagnostic vitros within-run precision testing to assess instrument performance was performed, therefore, an analyzer performance issue cannot be ruled out as contributing to the event.An ortho field application specialist (fas) went on site and cleaned the microtip area, replaced the photometer lamp, adjusted the export arm, ran a water blank and calibrated vitros hba1c reagent lot 2539-44-3184.However, the customer continued to use pack id 427 and obtained lower than expected results, therefore, it is unknown if the service actions performed by the ortho fas affected a performance issue with the vitros 5600 integrated system.Vitros hba1c reagent lot 2539-44-3184 pack id 427 was loaded on-board the vitros 5600 integrated system for four days which is within the on-board stability specification of is 28 days.Therefore, pack id 427 was within the on-board stability range.Therefore, expired on-board stability did not contribute to the event.No information was provided concerning the storage of pack id 427 prior to loading onboard the vitros 5600 integrated system.Therefore, it is unknown if pack id 427 was stored properly prior to the event.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected vitros hba1c reagent lot 2539-44-3184 results were obtained from two different levels of vitros %a1c performance verifier (pv) fluids on a vitros 5600 integrated system.Vitros %a1c pv i, lot w2392 vitros hba1c results of 4.06 and 4.09 % ngsp vs.The range of means midpoint of 5.73 % ngsp vitros %a1c pv ii, lot x2393 vitros hba1c results of 6.30, 7.55, 7.51 and 7.68 % ngsp vs.The range of means midpoint of 9.30 % 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 lower-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 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: 24777694
• Report Number: 1319808-2026-00019
• Device Sequence Number: 14968444
• Product Code: PDJ
• UDI-Device Identifier: 10758750030729
• UDI-Public: (01)10758750030729(17)261209(11)241209(10)443184
• Combination Product (Y/N): N
• 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): 04/02/2026

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: 6842905
• Device Lot Number: 2539-44-3184
• 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: 03/09/2026
• Initial Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2024
• 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