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	09/01/2026
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 hba1c results were obtained from a non-vitros biorad quality control processed using vitros chemistry products hba1c reagent lot 2539-51-3990 on a vitros xt 7600 integrated system.Biorad lot 89280 level 2 results of 10.2, 10.4, 10.4 and 10.5 %a1c vs an expected result of 8.6 %a1c 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 results were obtained from a control fluid and were not reported out of the laboratory.There has been no allegation of patient harm as a result of this event.This report is number one 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 101168810 and reportability assessment 615838.
Additional Manufacturer Narrative
The investigation determined that higher than expected hba1c results were obtained from a non-vitros biorad quality control processed using vitros chemistry products hba1c reagent lot 2539-51-3990 on a vitros xt 7600 integrated system.A definitive assignable cause of the event could not be determined with the information available.Based on previous quality control results, a vitros hba1c reagent lot 2539-51-3990 related issue was not a likely contributing factor of the event.Additionally, a reagent pack related issue was ruled out as a contributing factor of the event.A possible cause of the event could be within calibration reagent drift as the initial calibration was determined to be typical and initial quality control results were within expectations.A recalibration event seemingly resolved the issue.However, as it is unknown if the same biorad control vials were used following the recalibration event, an issue related to the biorad controls cannot be entirely ruled out as a contributing factor of the event.An instrument related issue cannot be entirely ruled out as a contributing factor of the event as precision testing was not performed on the vitros xt 7600 system.However, as the issue was resolved following a recalibration event without any known actions being performed on the vitros xt 7600 system, an instrument related issue was not a likely contributing factor of the event.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros hba1c lot 2539-51-3990.

• 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 ; +1(585)453-4165
• MDR Report Key: 50937674
• Report Number: 1319808-2026-00055
• Device Sequence Number: 9598118
• Product Code: PDJ
• UDI-Device Identifier: 10758750030729
• 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): 09/29/2026

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: 2539-51-3990
• 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: 09/02/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2026
• 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