MAUDE Adverse Event Report: HOLOGIC, INC. PANTHER INSTRUMENT; IN-VITRO DIAGNOSTIC

Catalog Number	902615
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/27/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer, (b)(6), reported the panel of their panther instrument 19" pcap glass touch screen monitor detached because the rubber band that is holding it in place snapped but the monitor was still usable.Hologic fse replaced the monitor to resolve issue.Hologic's risk assessment was completed on 21dec2017 after the monitor was returned for evaluation.It wasn't until the initial investigation was complete that hologic identified that this could cause injury and would be considered a reportable event.There are two associated risks that hologic assessed.The risk of incorrect results: per hologic's risk assessment, there is no impact to results as the monitor is used to display the graphical user interface and the instrument can continue to run without the touch panel.The severity associated with incorrect results is negligible since the instrument will continue to function as expected.The risk of operator injury: per hologic's risk assessment, the safety impact for possible medical intervention caused by the falling glass panel would have a serious severity rating.According to the supplier, the glass panel is made of shatter resistant glass and has smooth rounded edges, therefore, injury due to broken glass is unlikely.Although the glass panel is shatter resistant and did not break, a customer safety risk exists whereby the glass panel could cause injury due to the force of the impact striking a bystander as it falls from the base.The glass panel weight is approximately 0.5 kilograms and at worst could cause reversible injury that might require professional medical intervention.There have been 2 instances of monitors becoming detached; however, no injury has occurred.

• Brand Name: PANTHER INSTRUMENT
• Common Device Name: IN-VITRO DIAGNOSTIC
• Manufacturer (Section D): HOLOGIC, INC.; 10210 genetic center dr.; san diego CA 92121
• MDR Report Key: 7178250
• Report Number: 2024800-2018-00002
• Device Sequence Number: 19141848
• Product Code: LSL
• UDI-Device Identifier: 15420045504141
• UDI-Public: 15420045504141
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111409
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/10/2018

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: No Information
• Device Catalogue Number: 902615
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 01/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other