MAUDE Adverse Event Report: HOLOGIC, INC. APTIMA HPV SCREENING ASSAY; KIT, RNA DETECTION, HUMAN PAPILLOMAVIRUS

Catalog Number	303585
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On july 10, 2024, one customer reported to hologic that they had three discrepant results using the aptima hpv assay (lot 895916) on the panther instrument.The customer had been using hpv negative calibrators as an external quality control (eqc), that resulted positive while using master lot (ml) 895916.Due to the initial eqc result, the customer decided to retest all samples using the same aliquot and received three negative results upon retest.Hologic technical support informed the customer that hpv calibrators are single-use tubes and are not to be reused as an eqc.The customer decided to withhold the results due to initial eqc result, and reported the negative results to the patients accordingly.No patient treatment information was provided by the customer.Hologic has not learned of any adverse patient outcomes due to this event.
Additional Manufacturer Narrative
Hologic reviewed logs and kinetic curves provided by the customer.Hologic observed signs of positive and negative contamination.On july 23, 2024, a hologic molecular applications specialists (mas) visited the customer site and collected environmental swabs.The swabs were tested at hologic and indicated instrument and lab contamination.After multiple rounds of cleaning at the customer site, mas confirmed that the contamination was cleared, and the instrument was released to the customer.Hologic completed a risk assessment.There is no product impact.The inconsistent results were due to contamination found and confirmed at customer site and potential sample mishandling.Hologic has not learned of any adverse patient outcomes due to this event.

• Brand Name: APTIMA HPV SCREENING ASSAY
• Common Device Name: KIT, RNA DETECTION, HUMAN PAPILLOMAVIRUS
• 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: 19952879
• Report Number: 2024800-2024-00010
• Device Sequence Number: 18378070
• Product Code: OYB
• UDI-Device Identifier: 15420045500051
• UDI-Public: 15420045500051
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/09/2024

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 Catalogue Number: 303585
• Device Lot Number: 895916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 08/09/2024
• 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