MAUDE Adverse Event Report: Ortho-Clinical Diagnostics, Inc. VITROS Chemistry Products Calibrator Kit 2; In-Vitro Diagnostics

Catalog Number	1662659
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report that the operator sustained a thumb laceration during separate events involving the removal of metal seals from various vitros calibrator bottles.The operator did not seek medical attention or treatment for any of the injuries.No long-term serious injury was sustained.The operator did not seek medical treatment for the lacerations.The injury did not require any medical attention.There was no allegation of a serious or long-term permanent injury.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).
Additional Manufacturer Narrative
The investigation determined that the operator sustained a thumb laceration during separate events involving the removal of metal seals from various vitros calibrator bottles.The operator did not seek medical attention or treatment for any of the injuries.No long-term serious injury was sustained.The assignable cause of this event is user error.However, based on a medical consultation with an ortho medical safety officer (mso) on (b)(6) 2026: per the sds, the affected calibrators contain human-derived materials, and no known test method can provide complete assurance that infectious agents are absent.Although the materials used in manufacturing are tested for known blood-borne pathogens, the possibility of untested, emerging, or unknown infectious agents cannot be completely excluded.Because the operator sustained a cut while opening the product, contact between the wound and product contents cannot be ruled out.While no infection, medical treatment, or long-term sequelae have been reported and the likelihood of disease transmission is considered remote, infection resulting from exposure to human-derived materials cannot be definitively excluded.Given the potential for serious deterioration in health should transmission occur, this event is conservatively assessed as meeting the definition of a serious injury.

• Brand Name: VITROS Chemistry Products Calibrator Kit 2
• 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: 50882098
• Report Number: 1319808-2026-00054
• Device Sequence Number: 18818506
• Product Code: JIX
• UDI-Device Identifier: 10758750009503
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 1662659
• Device Lot Number: Not Provided
• 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: 09/04/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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