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	09/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that lower than expected hba1c results were obtained from two different lots of vitros performance verifier ii (pvii) fluids tested using vitros hba1c lot 1539-46-3073 on two vitros 4600 chemistry systems.The vitros hba1c results were low when compared the vitros pvii center of the range of means (crom).A definitive cause of the event was not established.The vitros hba1c results were generated during internal testing using vitros pv fluids.An hba1c pack was loaded onboard and tested every 7 days through day 28.A second reagent pack from the same lot was also tested every 7 days, then removed and stored refrigerated as a control.Qc results for the control pack remained within expectations at each interval.It was not documented whether the same pv fluids were used for both the control pack and the on-analyzer pack, so a pv fluid issue during day 28 testing cannot be ruled out.A reagent pack stability issue is not likely, as it is noted that typical stability issues present as a gradual drift rather than the abrupt shift observed on day 28, suggesting that there were unknown contributors to the low hba1c day 28 results.The investigation is ongoing.Ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros hba1c reagent lot 1539-46-3073.No diagnostic precision testing was performed on the vitros 4600 chemistry systems, however there was no indication that the instruments malfunctioned as there were no issues with any other assays.In addition, the hba1c results from the control pack were within expectation.
Event or Problem Description
An ortho clinical diagnostics (ortho) quality engineer contacted the ortho complaint handling unit (chu) to report lower than expected results obtained from a vitros %a1c performance verifier (pv) fluid tested using vitros hba1c reagent on two vitros 4600 chemistry systems.The vitros hba1c results were low when compared the vitros pvii center of the range of means (crom).Vitros s/n (b)(6), pvii n1620 results of 8.357, 8.386, 8.257, 8.305 versus the crom result of 10.42 vitros s/n (b)(6), pvii t2023 results of 9.257, 9.247, 9.170 versus the crom result of 10.43 biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The lower than expected vitros hba1c results were tested as part of internal testing using vitros pv fluids and no patient testing was performed.There was 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.Nonconformance nc0613539/ra613574.

• 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: 24455353
• Report Number: 1319808-2026-00009
• Device Sequence Number: 15780437
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/25/2026

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 Expiration Date: 08/02/2026
• Device Catalogue Number: 6842905
• Device Lot Number: 1539-46-3073
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 01/28/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 02/26/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown