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

Model Number	AC2, TIGRIS, 250 TESTS (REF)
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information provided by the customer was insufficient to characterize the sample as a confirmed false result.The initial ct-negative result was reported to the clinician, but the result was corrected after retesting the following day.The customer did not inform hologic whether the initial ct-negative result was reported to the patient or if the patient received any treatment for ct infection.Hologic reviewed the logs and found no hardware, kit chemistry, or kinetics issues.The assay is working as intended.The sample in question likely had low target that did not amplify during initial testing.Hologic completed a risk assessment and determined that the issue should cause minimal impact to the patient as the result should be considered in conjunction with all relevant clinical data.
Event or Problem Description
The customer reported to hologic that they received one discrepant ac2 result using assay lot 544905 run on panther instrument sn (b)(6).The sample in question initially resulted ct-negative and gc-positive (329 rlus) on (b)(6) 2023.The customer retested this sample on (b)(6) 2023 as part of the lab's qa process of retesting positive ac2 samples that have an rlu value less than 1000.The customer is aware the ac2 package insert (pi) instructs operators to report the first valid result for each analyte.The customer retested the same sample tube and confirmed the sample was stored according to the ac2 pi in between tests.Upon retest, the sample resulted ct-positive and gc-positive (2365 rlus).

• 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: kyleigh jacobs ; 10210 genetic center drive; san diego, CA 92121 ; 8584108566
• MDR Report Key: 17375340
• Report Number: 2024800-2023-00014
• Device Sequence Number: 20598396
• Product Code: LSL
• UDI-Device Identifier: 15420045505711
• UDI-Public: 15420045505711
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 07/21/2023

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 Model Number: AC2, TIGRIS, 250 TESTS (REF)
• Device Catalogue Number: 302661
• Device Lot Number: 544905
• 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: 06/23/2023
• Initial Report FDA Received Date: 07/21/2023
• 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