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

Catalog Number	302661
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On october 10th 2024, a customer reported three suspected false positive gc results using the aptima combo 2 assay.Samples were tested in worklist: 002536-20240916-45 ((b)(6)) & 002536-20241003-12 (24m113251 & 24m113075), using assay lots 899831 and 901175 on panther instrument serial number (b)(6) and tested positive for gc.Customer noted the results were questioned by the physician: two samples came from pregnant patients and the other sample came from a patient whose spouse tested negative for gc.One of the patients (sample id ((b)(6)) received treatment based on the positive gc result and no additional testing was performed.No negative impacts from the treatment were reported.Samples from the other two patients were recollected resulted gc negative.Hologic has not been informed of any adverse patient outcomes related to this situation.
Additional Manufacturer Narrative
Hologic technical support (ts) reviewed the logs provided by the customer and noted no hardware, software, or kit-related issues.Ts noted that all three samples had typical kinetics and did not find any indication of contamination.Ts noted that the samples were either mishandled or were true low-target samples.Hologic product application specialist (pas) provided a secondary review and confirmed there were no hardware or reagent preparation issues.Pas agreed that the samples were either mishandled or were low-target.Hologic performed a risk assessment and noted no product impact.Hologic has not been informed of any adverse patient outcomes related to this situation.

• Brand Name: APTIMA COMBO 2 ASSAY
• Common Device Name: DNA-REAGENTS, NEISSERIA
• 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: 20615478
• Report Number: 2024800-2024-00027
• Device Sequence Number: 15651565
• Product Code: LSL
• UDI-Device Identifier: 15420045505711
• UDI-Public: 15420045505711
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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
• Report Date (Section B): 11/05/2024

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: 302661
• Device Lot Number: 899831 & 901175
• 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: 10/07/2024
• Initial Report FDA Received Date: 11/05/2024
• 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
• Patient Sex: Unknown