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

Catalog Number	ASY-09835
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hologic thoroughly reviewed the panther logs and noted 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 to hologic questionable aptima hiv positive results using aptima hiv-1 quant dx assay (ml 894003), worklist (b)(4), on panther instrument serial number (b)(6).Customer noted that the patient contested the initial hiv positive result which prompted them to review amplification curves and initiate testing on a competitor platform.Customer retested the same sample on a competitor platform (genexpert) and edta and serum sample types both tested negative for hiv on the genexpert platform.Customer reported the male patient is on hiv antiretroviral therapy (art) and has tested hiv negative since 2015.Result was reported to have been amended to hiv negative upon testing on competitor platform.Patient treatment was not altered as a result of reported result.Hologic was not made aware 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: jiayi zheng ; 10210 genetic center drive; san diego, CA 92121
• MDR Report Key: 21510644
• Report Number: 2024800-2025-00008
• Device Sequence Number: 8021224
• Product Code: MZF
• UDI-Device Identifier: 15420045504219
• UDI-Public: 15420045504219
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 03/03/2025

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: 894003
• 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: 02/12/2025
• Initial Report FDA Received Date: 03/03/2025
• 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