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

Catalog Number	ASY-08187
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hologic reviewed the system logs and amplification curves as provided by the customer.Logfile review confirmed there were no signs of hardware issues with the instrument that could have interfered with the results.Review of the data from worklist id (b)(4) showed that the initial sample curve (sample id (b)(6)) exhibited a sudden jump in the fluorescent signal of the hiv-1 ltr target.As a result, the software produced a high titer result for this sample.It was noted that, after the occurrence of this artifact, the questionable amplification curve exhibited an amplification pattern that was in line with true ltr target amplification.Further review indicated that the other target and internal control curves in this sample exhibited nominal amplification.Hologic conducted a related event search on aptima hiv-1 quant dx assay master lot 907607 and found no other instances of atypical fluorescence results have been reported with this master lot.Hologic further reviewed the impacted master lot production records which indicated the assay lot was released as per qc specifications.
Event or Problem Description
On (b)(6) 2025, a customer questioned a result while using the aptima hiv-1 quant dx assay master lot 907607 on the panther instrument (sn (b)(6)).Customer tested sample id (sid) (b)(6) on (b)(6) 2025, on worklist (b)(4) and received a valid result of hiv-1 ¿detected¿ with 5,263 copies/ml.Customer reviewed amplification curves from this sample and determined they were unsatisfactory.Customer then decided to retest sid (b)(6) using a different aliquot of the plasma sample on (b)(6) 2025, on worklist (b)(4) and received a valid result of hiv-1 ¿detected¿ with 33 copies/ml.Based on these result discrepancies, the customer opted to report the result as ¿invalid¿ and requested a new sample from the patient.The customer reported that the impacted patient had a known clinical history of hiv infection with consistent negative viral loads in prior hiv tests.No information regarding patient treatment, gender, or the new sample¿s results were provided to hologic.Hologic has not learned of any adverse patient outcomes due to this reported incident.
Additional Manufacturer Narrative
The customer provided additional patient information to hologic: the affected samples were from a female patient, age 38.Customer noted they have not received or tested a new sample for this patient at this time, though a new sample was requested.No additional patient information or patient treatment information has been provided to hologic.Hologic has not learned of any adverse patient outcomes due to this reported incident.
Event or Problem Description
Follow-up report.See section h11.

• 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: grace nareau ; 10210 genetic center drive; san diego, CA 92121 ; 8584108040
• MDR Report Key: 22906624
• Report Number: 2024800-2025-00057
• Device Sequence Number: 7911171
• Product Code: MZF
• UDI-Device Identifier: 15420045504219
• UDI-Public: 15420045504219
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 09/03/2025

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-08187
• Device Lot Number: 907607
• 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: 08/12/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 09/03/2025
• 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 Age: 38 YR
• Patient Sex: Female