MAUDE Adverse Event Report: HOLOGIC, INC. APTIMA MYCOPLASMA GENITALIUM ASSAY; NUCLEIC ACID DETECTION SYSTEM FOR NON-VIRAL MICROORGANISM(S)

Catalog Number	ASY-09407
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hologic reviewed the panther logs and worklists and noted there were no indications of hardware or reagent preparation issues that affected results.Customer noted that there was a possibility the samples were swapped.Hologic has not learned of any patient treatment or adverse patient outcomes due to this event.
Event or Problem Description
On (b)(6) 2026, customer reported receiving discrepant results while using the aptima mycoplasma genitalium assay (ml 920257) on a patient sample that was part of their bi-annual instrument comparison study.On (b)(6) 2026, customer tested samples on the panther instrument sn (b)(6) with worklist (wl) id (b)(4) and received a negative result for sample id (b)(6).On (b)(6) 2026, customer tested samples on the panther instrument sn (b)(6) with wl id (b)() and received a positive result for sample id (b)(6).On (b)(6) 2026 customer retested samples id (b)(6) on a different panther instrument sn (b)(6) with wl id (b)(4).A positive result was received for sample id (b)(6) and a negative result was received for sample id (b)(6).On (b)(6) 2026, customer retested both samples one more time on the panther instrument sn (b)(6) with wl id (b)(4) and received the same results, positive for sample id (b)(6) and negative for sample id (b)(6).Customer noted that there was a possibility that the sample ids were swapped during the second and third retests.Customer did not provide any information on the patient or patient treatment.Hologic has not been informed of any adverse patient outcomes related to this issue.

• Brand Name: APTIMA MYCOPLASMA GENITALIUM ASSAY
• Common Device Name: NUCLEIC ACID DETECTION SYSTEM FOR NON-VIRAL MICROORGANISM(S)
• 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: maria osorio ; 10210 genetic center drive; san diego, CA 92121
• MDR Report Key: 25411000
• Report Number: 2024800-2026-00029
• Device Sequence Number: 9465358
• Product Code: QEP
• UDI-Device Identifier: 15420045509146
• UDI-Public: 15420045509146
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: DEN180047
• 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): 06/05/2026

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-09407
• Device Lot Number: 920257
• 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: 05/22/2026
• Initial Report FDA Received Date: 06/05/2026
• 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