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	11/18/2024
Type of Reportable Event	Malfunction
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.The recollected sample did not show an atypical fluorescence curve and produced a ¿not detected¿ result.The initial sample was not retested.Hologic field service upgraded the panther system software to the latest version on 11/21/2024 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.H3 other text: other.
Event or Problem Description
On (b)(6) 2024, customer reported to hologic that they were questioning a positive result using the aptima hiv-1 quant dx assay (ml 897723), worklist: (b)(4), on panther instrument serial number: (b)(6).Customer noted the positive result was reported out to the physician.The physician sent in a recollected sample from the same patient and it returned a ¿not detected¿ result.The initial sample was not retested.Customer noted the patient was on a pre-exposure prophylaxis (prep) medication regimen since on (b)(6) 2024 and no change in treatment was reported to hologic in association with this issue.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: 20926931
• Report Number: 2024800-2024-00062
• Device Sequence Number: 20100823
• Product Code: MZF
• UDI-Device Identifier: 15420045504219
• UDI-Public: 15420045504219
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/13/2024

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: 897723
• 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: 11/18/2024
• Initial Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (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