MAUDE Adverse Event Report: HOLOGIC, INC. DX INSTRUMENTS; HOLOGIC PANTHER, INSTRUMENT SYSTEM

Model Number	9120900000
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	07/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hologic conducted interviews with customer and inquired if operator was following recommended protective requirements as outlined in panther system operator manual (aw-26055-001 - "manual, operator's, panther/panther fusion 7.2, global, ivd, english, ivdr").Customer confirmed that the operator was not wearing protective eyewear during incident.Hologic was informed that impacted operator did not suffer permanent damage or injury to the left-eye.Operator is currently cleared for work and has no reduced vision.A red spot next to the pupil is however still visible on the white of the eye however operator is claiming situation is improving over time.Following the incident, hologic reshared a customer technical bulletin with customer (ctb-00227_003_01 - "system liquid waste composition information for the panther system, panther plus system and panther fusion system") detailing the composition of liquid waste.Hologic further reemphasized the importance of adhering to general good laboratory practices and stressed the importance to follow correct operating procedures when handling the system and liquids as outlined in the instrument operator manual.Hologic defines this incident as a user error.No further investigation or event mitigatory actions are required at this time.
Event or Problem Description
During hologic service visit to site on (b)(6) 2022, customer informed hologic of an injury event that happened on (b)(6) 2022.Hologic was not aware of the incident prior to service visit as customer did not report injury to hologic.Customer relayed that during the emptying of liquid waste of panther (sn (b)(4) into the laboratory sink, an operator (female) received a droplet/splash of liquid waste into her left eye.Operator immediately rinsed affected eye with sterile saline water eye flush solution and contacted a physician within 24 hours.Medical doctor decided to commence treatment of injury with antibiotics, cortisone and anti-inflammatory medication.Hologic was informed that affected operator is still receiving treatment at time of event reporting (b)(6) 2022).Customer also stated operator had visited physician 4 times since time of incident.Photographic evidence of the injury was provided to hologic on which a red area next to the pupil of the left eye is observable.Customer is running hbv, hcv and hiv assay on panther system (b)(4).

• Brand Name: DX INSTRUMENTS
• Common Device Name: HOLOGIC PANTHER, INSTRUMENT SYSTEM
• 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: kyleigh jacobs ; 10210 genetic center drive; san diego, CA 92121 ; 8584108566
• MDR Report Key: 15536163
• Report Number: 2024800-2022-01094
• Device Sequence Number: 17464390
• Product Code: LSL
• UDI-Device Identifier: 15420045504141
• UDI-Public: 15420045504141
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K220321
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/03/2022

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
• Device Model Number: 9120900000
• Device Catalogue Number: 902615
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2022
• Initial Report FDA Received Date: 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown