MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS 5600 INTEGRATED SYSTEM; CHEMISTRY ANALYZER

Catalog Number 6802413

Device Problem Device Handling Problem (3265)

Patient Problem Laceration(s) (1946)

Event Date 02/24/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation determined an ortho field engineer (fe) sustained a minor cut to the middle finger of his right hand when working to the rear of the motion controller and power transformer on a vitros 5600 integrated system.The ortho fe was wearing gloves at the time of the event but did not undertake any basic medical first aid such as washing the cut and applying a band aid at the time of the event and continued working.This has resulted in an infection of the finger requiring a minor medical procedure.The most likely assignable cause of this event is user error and failure to follow good laboratory practice.(b)(4).

Event Description

The investigation determined an ortho field engineer (fe) sustained a minor cut to the middle finger of his right hand when working to the rear of the motion controller and power transformer on a vitros 5600 integrated system.Based on a medical consult with ortho medical safety officer, dr (b)(4) on 16 march 2022 regarding this event, it was deemed consistent with a minor cut and not a serious injury.It is unlikely there would be any permanent impact to the function of the finger or the right hand due to this incidence and as such the event is not reportable.The incident has been reported locally as an occupational accident and a minor surgical intervention was performed, with an abundance of caution.The ortho complaint handling unit has taken the decision to conservatively report this event.The ortho fe is reported to be recovering well and there are no anticipated long-term effects from this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint (b)(4).

• Brand Name: VITROS 5600 INTEGRATED SYSTEM
• Type of Device: CHEMISTRY ANALYZER
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 13871090
• MDR Text Key: 297680687
• Report Number: 1319681-2022-00013
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 6802413
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1