MAUDE Adverse Event Report: HOLOGIC, INC. THINPREP® 5000 AUTOLOADER; THINPREP 5000

Model Number	T5000
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported to hologic that they experienced a urine staining problem that resulted in incorrect results and a misdiagnosis.The customer reported red spots on the cell¿s cytoplasm and also a ¿red bath¿ observed from the thinprep® 5000 autoloader instrument.Hologic has confirmed that no red dyes or materials are present in the thinprep® 5000 autoloader.Hologic¿s cytology applications specialist (cas) has contacted the customer multiple times to obtain additional information regarding the nature of the misdiagnosis, the associated patient outcome, the type of imager used, and further details on the alleged instrument issue; however, no additional information has been provided to date.
Additional Manufacturer Narrative
Additional information received: it was reported from the laboratory management that the cytotechnologist observed intermittent issues with stained cytology slides, where cells, often at the edges, were stained red.The customer reported that these staining issues resulted in a misinterpretation of a prepared slide.The sample was sent to histology for further evaluation where the correct diagnosis was confirmed.Complaint investigation completed: a direct correlation between the reported staining issue and the t5000 autoloader could not be established.The customer reported intermittent urine staining problems, including red spots on the cytoplasm and red staining residue on the instrument¿s stain buckets, which led to a misinterpretation of a slide.Customer-provided images showed a red residue on one stain bath and a pinkish hue in two others.Hologic scientific product support reviewed the images and could not determine a definitive root cause.It is possible the red residue and pink solution were related to thinprep stain ea solution, as stain dyes can accumulate and dry on racks; if racks are not adequately cleaned, dye may leach into the 95% alcohol holding bath, turning it pink.Complaint/case history shows that hologic personnel were onsite in april 2025 for similar staining issues.At that time, the customer was not using cytolyt cups and was not following the recommended staining protocol; they were reeducated, and a follow-up in september 2025 indicated issues had resolved.In december 2025 the customer reported a return of intermittent staining issues.They stated they were following the april protocol and daily maintenance and noted occasional similar issues on pap slides, for which they contact hologic.The customer has been advised to have their chemistry department evaluate their water, complete a stain assessment, and schedule an onsite visit for program adjustments.No confirmation of resolution or service visits has been received.The root cause of the staining issue and subsequent slide misinterpretation remains inconclusive.The sample was sent to histology for further evaluation where the correct diagnosis was confirmed, therefore no patient mistreatment occurred.Future events will be monitored and trended.No additional corrective actions or investigations are warranted at this time.

• Brand Name: THINPREP® 5000 AUTOLOADER
• Common Device Name: THINPREP 5000
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer (Section G): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: caroline bartlett ; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 24045343
• Report Number: 1222780-2026-00020
• Device Sequence Number: 9260762
• Product Code: MNM
• UDI-Device Identifier: 15420045513952
• UDI-Public: (01)15420045513952
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: T5000
• Device Catalogue Number: ASY-03098
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2022
• 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