MAUDE Adverse Event Report: HOLOGIC, INC. APTIMA HPV 16 18/45 GENOTYPE ASSAY; KIT, RNA DETECTION, HUMAN PAPILLOMAVIRUS

Catalog Number	303230
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer originally reported invalid samples results on aptima hpv 16 18/45 genotype (ahpv-gt) assay worklist (wl) (b)(4).Hologic reviewed panther logs and worklists provided and noted indications of potential reagent kit preparation issues that may have impacted valid results on this worklist.Hologic recommended customer to repeat samples from wl (b)(4) with a newly prepared reagent kit.Hologic has not been informed of any adverse patient outcomes related to this issue.
Event or Problem Description
On (b)(6) 2026, customer reported that they received discrepant results on three samples ids (sids) (b)(6) while running the aptima hpv 16 18/45 genotype (ahpv-gt) assay (ml 920131) on their panther plus instrument (sn: (b)(6).On (b)(6) 2026, customer initially tested all three samples on ahpv-gt worklist (wl) (b)(4) and received valid hpv 16 negative and hpv 18/45 negative results for these samples.Due to potential reagent kit preparation issues with the initial worklist, customer later retested all samples from wl (b)(4) using the same sample tube on (b)(6) 2026, with wl (b)(4) using a new reagent kit on the same panther instrument.Sids (b)(6) resulted hpv 16 positive and hpv 18/45 negative upon retest, while sid (b)(6) resulted hpv 16 negative and hpv 18/45 positive on retest.In addition, customer also tested new aliquots of these samples in wl (b)(4).New aliquots of sids (b)(6) resulted hpv 16 positive and hpv 18/45 negative and new aliquot of sid (b)(6) resulted hpv 16 negative and hpv 18/45 positive.Customer did not confirm which sample results were reported out or amended nor did customer provide any information on patients or patient treatment.Hologic has not been informed of any adverse patient outcomes related to this issue.

• Brand Name: APTIMA HPV 16 18/45 GENOTYPE 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: grace nareau ; 10210 genetic center drive; san diego, CA 92121 ; 8584108040
• MDR Report Key: 24308439
• Report Number: 2024800-2026-00003
• Device Sequence Number: 5227874
• Product Code: OYB
• UDI-Device Identifier: 15420045500112
• UDI-Public: 15420045500112
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P120007
• 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): 02/10/2026

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: 303230
• Device Lot Number: 920131
• 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: 01/27/2026
• Initial Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (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