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	12/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that higher than expected hba1c results were obtained from non-vitros mas quality controls as well as samples from multiple different patients processed using vitros chemistry products hba1c reagent lot 1539-45-3329 on a vitros 5600 integrated system.The investigation could not determine a definitive assignable cause of the event.Based on historical quality control results, a vitros hba1c lot 1539-45-3329 performance issue is not a likely contributor of the event.However, an individual pack related issue could not be ruled out as all of the unacceptable results were obtained using one reagent pack.The customer switched to an alternate reagent lot and did not attempt further troubleshooting using lot 1539-45-3329.An instrument related issue could not be entirely ruled out as a contributing factor of the event as diagnostic precision testing was not performed on the vitros 5600 integrated system to verify performance.Additionally, metering condition codes were obtained on the vitros 5600 system around the timeframe of the event, however, the metering issues did not likely cause the higher-than-expected results.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros hba1c lot 1539-45-3329.
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 non-vitros mas quality controls as well as samples from multiple different patients processed using vitros chemistry products hba1c reagent lot 1539-45-3329 on a vitros 5600 integrated system.Mas lot dbcl2605 level 1 results of 6.96, 6.99, and 7.12 %a1c vs an expected result of 5.21 %a1c mas lot dbcl2605 level 2 results of 11.88, 11.89 and 12.30 %a1c vs an expected result of 8.04 %a1c patient 1 result of 11.6 %a1c vs an expected result of 6.6 %a1c patient 2 result of 8.3 %a1c vs an expected result of 6.7 %a1c patient 3 result of 9.2 %a1c vs an expected result of 6.4 %a1c patient 4 result of 7.3 %a1c vs an expected result of 5.5 %a1c patient 5 result of 6.4 %a1c vs an expected result of 4.8 %a1c patient 6 result of 7.0 %a1c vs an expected result of 5.0 %a1c patient 7 result of 6.8 %a1c vs an expected result of 4.8 %a1c biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The higher-than-expected patient sample results were reported out of the laboratory.However, no treatment was initiated, altered or stopped based on the reported results and corrected reports for the patients were later issued.There has been no reported 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 613072.

• 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: 24052991
• Report Number: 1319808-2026-00001
• Device Sequence Number: 9495002
• Product Code: PDJ
• UDI-Device Identifier: 10758750030729
• UDI-Public: (01)10758750030729(17)261209(11)241209(10)453329
• 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): 01/13/2026

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: 45-3329
• 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: 12/15/2025
• Initial Report FDA Received Date: 01/13/2026
• 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