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	06/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On june 5, 2025, a customer reported questioning results using the aptima hiv-1 quant dx assay master lot 911588 on panther plus instrument sn# (b)(6).The customer noted that samples from the patient were collected in both serum separator tubes (sst) and plasma preparation tubes (ppt).The discrepant results are as follows: sample id (b)(6) retested as (b)(6): ¿ on (b)(6) 2025, the sst was first tested in panther worklist: (b)(4) and resulted as ¿not detected¿.¿ on (b)(6) 2025, the same sst tube was retested on panther and resulted as <30 detected in panther worklist: (b)(4).Customer also tested a ppt sample from the same patient in this worklist and this sample resulted as 182 copies/ml.The ppt tube was also tested on a roche instrument and customer stated this resulted as 567 copies/ml.The customer stated that all hiv results are subject to their review process before determining which result to report.However, the customer did not know which result(s) were reported for sample id (b)(6) and is unable to verify this information.No patient treatment information was provided by the customer.Hologic has not learned of any adverse patient outcomes due to this event.
Additional Manufacturer Narrative
Hologic technical support (ts) reviewed logs and kinetic curves for both initial test worklist (b)(4) and retest worklist (b)(4).No hardware, software or contamination issues were found.Ts informed the customer that results from different sample tubes cannot be directly compared.Ts indicated that the discrepant result was most likely due to the sample low target or sample mishandling.Hologic completed a risk assessment.There is no product impact.Hologic has not learned of any adverse patient outcomes due to this event.H3 other text: other.

• 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: 22366145
• Report Number: 2024800-2025-00039
• Device Sequence Number: 12901749
• Product Code: MZF
• UDI-Device Identifier: 15420045504219
• UDI-Public: 15420045504219
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 06/30/2025

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: 911588
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 06/30/2025
• 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