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

Catalog Number	6842905
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected vitros %a1c results were obtained from a single sample processed using vitros chemistry products hba1c reagent lot: 1539-45-3118 on a vitros 5600 integrated system.The results were higher than expected when compared to the result obtained on from a finger capillary puncture sample using a siemens dca vantage point of care (poc) test system.Vitros %a1c sample results of 6.7% and 6.9% vs the expected result of 5.5% 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 a sample obtained from the vitros operator at the customer site for troubleshooting purposes only and was not reported outside of the laboratory.There was no allegation of patient harm as a result of this event.This report is number two of two mdrs for this event.Two 3500a forms are being submitted for this event as two devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number: (b)(4).
Additional Manufacturer Narrative
The investigation determined that higher than expected vitros %a1c results were obtained from a single sample processed using vitros chemistry products hba1c reagent lot: 1539-45-3118 on a vitros 5600 integrated system.The results were higher than expected when compared to the result obtained on from a finger capillary puncture sample using a siemens dca vantage point of care (poc) test system.The assignable cause cannot be determined with the information provided.Historical vitros hba1c lot: 1539-45-3118 results were within expectation; therefore, a reagent issue is not a likely contributor to the event.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: 1539-45-3118.It is unknown if the customer was following the tube manufacturers guidelines for sample preparation and it is possible that cellular debris, due to poor sample preparation, was present in the affected samples, although this could not be confirmed.Diagnostic 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.

• 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: 24552175
• Report Number: 1319808-2026-00015
• Device Sequence Number: 14852321
• Product Code: PDJ
• UDI-Device Identifier: 10758750030729
• UDI-Public: (01)10758750030729(17)261209(11)241209(10)453118
• 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): 03/09/2026

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: 1539-45-3118
• 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: 02/09/2026
• Initial Report FDA Received Date: 03/09/2026
• 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