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	05/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hologic reviewed available logs for both initial test worklist (b)(4) and retest worklist (b)(4) and found no hardware or reagent preparation issues.The initial positive result exhibited an expected amplification curve shape, indicating successful amplification of the target.Log review could not exclude the possibility of sample mishandling/contamination.
Event or Problem Description
On (b)(6) 2025, customer reported to hologic that they were questioning a positive result using the aptima hiv-1 quant dx assay (ml 895102), on panther instrument serial number (b)(6).The patient, a pregnant woman, sample id: (b)(6), was tested at delivery and produced an hiv-1 ¿detected¿ result in worklist (b)(4).The clinician noted that the sample was retested as they routinely request retesting for such cases which produced an hiv-1 ¿not detected¿ result.On (b)(6) 2025, the customer reported to hologic that, as it concerned a pregnant woman and the positive result would have potentially altered the treatment of the mother and delivery.On june 12, 2025, hologic became aware that the patient results had been reported out.On (b)(6) 2025, it was confirmed that the results could potentially impact the post-exposure prophylaxis (pep) management of a neonate.On (b)(6) 2025, the clinician noted that the baby was due to receive pep as the mother was known to be hiv positive, and a detectable viral load at birth impacts duration and type of pep.The clinician was not aware whether the neonate experienced any adverse side effects from the pep administration.

• 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: 22331483
• Report Number: 2024800-2025-00038
• Device Sequence Number: 18214981
• 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): 06/25/2025

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: 895102
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 06/25/2025
• 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