MAUDE Adverse Event Report: HOLOGIC, INC. APTIMA COMBO 2 ASSAY; DNA-REAGENTS, NEISSERIA

Catalog Number	PRD-05571
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hologic reviewed logs and amplification curves provided by the customer.Hologic observed signs of a low-level target concentration in the sample, which could produce positive results if amplified.Log review could not determine if the low-level target originated from the specimen or was introduced via sample tube cross-contamination.The customer confirmed the retest of this sample was unintentional.Hologic informed the customer that if the customer questioned the result based on the discrepant result in conjunction with patient history, customer could obtain a new/fresh sample and retest to exclude the possibly of sample to sample cross-contamination.Hologic completed a risk assessment and found no product impact.It could not be confirmed whether the inconsistent results were due to low sample target concentration or cross-contamination.Hologic has not been informed of any patient treatment or adverse patient outcomes related to this event.
Event or Problem Description
On (b)(6) 2024, one customer in the united kingdom reported to hologic that they had a potential false negative result for neisseria gonorrhoeae (gc) while using the aptima combo 2 assay (lot number 899222) on the panther instrument (serial number (b)(6)).Customer tested the same sample tube (sample id (b)(6)) twice on the same worklist (b)(4).The initial result was chlamydia trachomatis (ct) negative, gc negative; the retest of the sample produced a ct negative, gc positive result.The customer reported out the initial ct negative, gc negative result prior to realizing the sample retested with a discrepant gc result.No information on patient treatment was provided by the customer.Hologic has not learned of any adverse patient outcomes due to this event.
Additional Manufacturer Narrative
Section b, box 4 in the initial report did not include the "date of this report." the initial report was submitted on 14-jan-2025.
Event or Problem Description
Follow-up report.See section h11.

• Brand Name: APTIMA COMBO 2 ASSAY
• Common Device Name: DNA-REAGENTS, NEISSERIA
• Manufacturer (Section D): HOLOGIC, INC.; 10210 genetic center drive; 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: 21151355
• Report Number: 2024800-2025-00002
• Device Sequence Number: 15736892
• Product Code: LSL
• UDI-Device Identifier: 15420045505711
• UDI-Public: 15420045505711
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K111409
• 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): 01/14/2025

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: PRD-05571
• Device Lot Number: 899222
• 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: 12/31/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 01/14/2025
• 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