MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS 3600 IMMUNODIAGNOSTIC SYSTEM; CHEMISTRY ANALYZER

Catalog Number 6802783

Device Problem Leak/Splash (1354)

Patient Problem Exposure to Body Fluids (1745)

Event Date 01/16/2024

Event Type  Injury  

Event Description

A customer reported that when the operator opened the vitros 3600 immunodiagnostic system's microwell incubator they were splashed in their eyes with fluid from microwells stuck to the incubator cover.The splash happened when the wells stuck to the cover fell back into the incubator.This incidence is considered as blood borne pathogen exposure to the mucosa.The customer was performing patient sample testing using vitros microwell assays including the vitros anti-hcv assay when the event occurred.Due to the potential pathogen contents and pathogen concentrations in the microwell, a potential transmission of blood borne pathogen via this incident cannot be excluded.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number 32231870 and reportability assessment 604909.

Manufacturer Narrative

The investigation determined that when the operator opened the vitros 3600 immunodiagnostic system's microwell incubator they were splashed in their eyes with fluid from microwells stuck to the incubator cover.The splash happened when the wells stuck to the cover fell back into the incubator.The root cause of the exposure is user error, as the operator did not use proper personal protection equipment (safety glasses) while opening the microwell incubator cover to address a mechanical issue with the microwell incubator.The customer was wearing their prescription eyeglasses but not safety glasses.The customer flushed both eyes immediately after the event.Blood samples were collected from the operator for infectious disease testing but the results of the testing were not provided.The operator will be monitored for any health issues.As per medical consultation with an ortho medical safety officer received on (b)(6) 2024: exposure of the eyes to blood-borne pathogens such as hepatitis c or hepatitis b carries a risk of contracting an infection.There is currently no post-exposure prophylaxis for hepatitis c.However, the risk of contracting hepatitis c infection from a splash in the eyes is considered low.Hepatitis b virus risk of infection may be reduced if the operator is immune to hepatitis b, or they may receive hepatitis b vaccine and hepatitis b be reduced if the operator is immune to hepatitis b, or they may receive hepatitis b vaccine and hepatitis b immunoglobulin.Due to the uncertainty in the risk of infection, this incidence is considered a serious injury and is therefore reportable.

• Brand Name: VITROS 3600 IMMUNODIAGNOSTIC SYSTEM
• Type of Device: CHEMISTRY ANALYZER
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 18721489
• MDR Text Key: 335701937
• Report Number: 1319681-2024-00011
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 6802783
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1