MAUDE Adverse Event Report: HOLOGIC INC. LEADER LUMINOMETER; IN-VITRO DIAGNOSTICS

Catalog Number R104747-01

Device Problem Insufficient Information (3190)

Patient Problems Red Eye(s) (2038); Swelling (2091); Reaction (2414)

Event Date 01/12/2017

Event Type  Injury  

Event Description

The customer (b)(6), experienced a reaction when working with bleach while cleaning materials in the lab.Approximately after 2 hours, the operator had red swollen eyes and patches under the eyes.She did not touch her face with her gloves, but did use the collar of her lab coat to wipe her face.There were no immediate actions taken, as the reaction took place after she had left for the day.The operator had been testing since (b)(6) 2016 and had eye swelling occurred on different occasions.She does not use harsh chemicals at home and only recently suspected the reaction is due her work with aptima.The operator did seek medical attention.The doctor has indicated that the fumes could be irritating her eyes, but perhaps rubbing the face with the lab coat could also cause the reaction.The operator is currently not performing aptima testing for the remainder of jan and feb.If the problem persists in march when the operator resumes aptima testing they will contact hologic.

• Brand Name: LEADER LUMINOMETER
• Type of Device: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): HOLOGIC INC.; 10210 genetic center drive; san diego CA 92121
• Manufacturer (Section G): HOLOGIC, INC.; 10210 genetic center drive; san diego CA 92121
• Manufacturer Contact: juliette busse ; 10210 genetic center drive; san diego, CA 92121 ; 8584108799
• MDR Report Key: 6312855
• MDR Text Key: 66863532
• Report Number: 2024800-2017-00005
• Device Sequence Number: 1
• Product Code: JJQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: R104747-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention