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	08/04/2026
Type of Reportable Event	Malfunction

• 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: 50569445
• Report Number: 1319808-2026-00048
• Device Sequence Number: 21459581
• 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): 09/01/2026

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: 2539-49-3807
• 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: 08/06/2026
• Initial Report FDA Received Date: 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2025
• 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