MAUDE Adverse Event Report: HOLOGIC, INC BOX OF COLLECTION KITS, VAGINAL SWAB; IN VITRO DIAGNOSTICS

Catalog Number	301162
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/18/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer, (b)(6) at (b)(6), called to report one of their collection sites, (b)(6) hospital lab, had been using vaginal swab collection kits to collect endocervical specimens.The site had depleted their stock of unisex swab collection kits.Hologic technical support advised the customer that this is off label and that only the unisex swab collection kit should be used to collect endocervical swab specimens.The site ran off pi for about one week.The customer tested these swab specimens with the aptima combo 2 and aptima trichomonas vaginalis assays.Hologic evaluated this issue and determined the risk to be serious as an incorrect or invalid result due to improper or inadequate sample collection may result in a delay or failure to identify a condition that requires medical intervention.The customer may report incorrect patient results as the result of testing an improper sample type.Endocervical swab specimens collected using the aptima vaginal swab specimen collection have not been evaluated for use with the aptima combo 2 or aptima trichomonas vaginalis assays.Hologic ts advised the customer to use the correct type of swab only per pi.

• Brand Name: BOX OF COLLECTION KITS, VAGINAL SWAB
• Common Device Name: IN VITRO DIAGNOSTICS
• Manufacturer (Section D): HOLOGIC, INC; 10210 genetic center dr; san diego CA 92121
• MDR Report Key: 6867476
• Report Number: 2024800-2017-00022
• Device Sequence Number: 890497
• Product Code: LIO
• UDI-Device Identifier: 25420045506258
• UDI-Public: 25420045506258
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K003395
• 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): 09/14/2017

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: 301162
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/14/2017
• 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