MAUDE Adverse Event Report: HOLOGIC, INC. APTIMA COMBO 2; IN-VITRO DIAGNOSTICS

Catalog Number	301041-01
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); Unspecified Infection (1930)
Date of Event	03/07/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer, (b)(6), called to report that one of their technicians was using the aptima unisex collection kit to collect a rectal patient sample, which is not consistent with the collection kit package insert.The operator ((b)(6)) collected the patient swab and placed the swab into the collection tube.Prior to closing the collection tube, transport media containing the patient swab splashed into the operator's eye.The operator then washed her eye with water and cleaned the skin with soap and water.The operator was wearing glasses at the time of sample collection, but was not wearing safety glasses.The patient sample was tested with the aptima combo 2 (ac2) assay, and the results were dual (b)(6) for (b)(6).The operator was examined by a doctor and will continue to be monitored, but no medications or antibiotics have been prescribed.Per hologic's risk assessment, as a result of patient sample exposure, the operator may have been infected.The sample is known to be (b)(6) for (b)(6), but the presence of other potentially infectious organisms cannot be known.

• Brand Name: APTIMA COMBO 2
• Common Device Name: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): HOLOGIC, INC.; 10210 genetic center drive; san diego CA 92121
• MDR Report Key: 7393103
• Report Number: 2024800-2018-00004
• Device Sequence Number: 11036598
• Product Code: LIO
• UDI-Device Identifier: 25420045506272
• UDI-Public: 25420045506272
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K132251
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/03/2018

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: 301041-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 04/03/2018
• 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