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	01/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hologic thoroughly reviewed the panther logs 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 informed the customer that their instruments will be upgraded to software version 7.4 to improve performance in the ltr channel for the aptima hiv-1 quant dx assay.Hologic also 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 january 16th, 2025, customer reported to hologic that they were questioning a positive result using the aptima hiv-1 quant dx assay (ml 904418), worklist wl (b)(4), on panther instrument serial number (b)(6).Customer noted the positive result was reported to the physician.Physician did not administer treatment or medication and questioned the result due to the patient being on medication to keep their viral load low.Customer retested the initially positive sample and obtained a negative result.Customer amended the result to negative.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: geovan rich ; 10210 genetic center drive; san diego, CA 92121 ; 6199972348
• MDR Report Key: 21289018
• Report Number: 2024800-2025-00005
• Device Sequence Number: 9355429
• Product Code: MZF
• UDI-Device Identifier: 15420045504219
• UDI-Public: 15420045504219
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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): 01/31/2025

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: 904418
• 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: 01/17/2025
• Initial Report FDA Received Date: 01/31/2025
• 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