MAUDE Adverse Event Report: HOLOGIC, INC. APTIMA HIV-1 QUANT DX ASSAY; TEST, HIV DETECTION

Catalog Number	ASY-09835
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hologic reviewed the panther logs and kinetic curves for worklist 000940-20250606-03 and noted that the initial sample curve exhibited an atypical low baseline fluorescence.This low fluorescence returned to normal early in the assay process.As a result, the software produced a high titer result for this sample.Hologic performed a risk assessment.Over-quantification of hiv viral load may lead to a change in antiretroviral therapy (art) or unnecessary initiation of art treatment.However, under standard hiv viral load monitoring guidelines, a change in patient viral load is to be confirmed prior to change in patient treatment.In addition, upon initiation of art treatment, clinicians are expected to interpret assay results in conjunction with patient history and other available data.Hologic has not been informed of any patient treatment or any adverse patient outcomes related to this event.
Event or Problem Description
On (b)(6) 2025, a customer reported questioning results using the aptima hiv-1 quant dx assay master lot: 896020 on panther plus instrument sn#: (b)(6).The customer noted sample id: (b)(6) was tested in panther worklist: 000940-20250606-03 and resulted with >10,000,000 copies/ml but the sample curve was poor.On (b)(6) 2025, the customer stated that they have no remaining sample left for retesting as the remaining sample was sent to the reference laboratory for testing.The reference laboratory was unable to amplify any product.On (b)(6) 2025, customer stated that the >10,000,000 copies/ml result was reported out to the consultant.No information regarding patient treatment was provided.Hologic has not learned of any adverse patient outcomes due to this event.

• Brand Name: APTIMA HIV-1 QUANT DX ASSAY
• Common Device Name: TEST, HIV DETECTION
• 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: katrina tarroja ; 10210 genetic center drive; san diego, CA 92121
• MDR Report Key: 22523575
• Report Number: 2024800-2025-00043
• Device Sequence Number: 9231565
• Product Code: MZF
• UDI-Device Identifier: 15420045504219
• UDI-Public: 15420045504219
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: BP150318
• 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): 07/16/2025

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: ASY-09835
• Device Lot Number: 896020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 07/16/2025
• 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