MAUDE Adverse Event Report: HOLOGIC, INC. PANTHER INSTRUMENT; HOLOGIC PANTHER, INSTRUMENT SYSTEM

Catalog Number	PRD-05490
Medical Device Problem Code	Missing Test Results (3267)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hologic reviewed the panther logs and worklists and confirmed multiple instrument error messages were generated during sample rack loading.The customer was provided with new sample racks however this did not resolve the issue.Hologic fse was dispatched on (b)(6) 2026.Fse removed and replaced the sample bay module and confirmed rack presence and barcode sensing in all eight lanes met specifications.As of (b)(6) 2026, no further issues have been reported.The sample bay module manufacturer, stratec, was notified.Per stratec¿s root cause analysis, the issue was due to a user sample rack loading error.Hologic has not been informed of any adverse patient outcomes related to this issue.
Event or Problem Description
On (b)(6) 2026, customer reported that they were unable to locate the results for a rack of samples tested on (b)(6) 2026, on the panther fusion plus instrument (sn (b)(6).On (b)(6) 2026, customer stated that samples in rack 589-01 in worklist (wl) (b)(4) had incorrect sample ids that belonged to samples that were not pierced.(sid) (b)(6) was reported out as ct positive/gc negative and was later retested as negative on (wl) (b)(4) and amended to ct negative / gc negative.All other (sids) in the affected rack 589-01 had the same result upon retesting in (wl) (b)(4) and remained ct negative/gc negative.On february 13th and 14th 2026, hologic technical support reviewed the logs and noticed there were multiple error messages related to the rack id barcodes or positional barcodes not reading or missing on sample racks.On (b)(6) 2026, customer reported that they used new sample racks and continued to have loading issues.Technical support reviewed logs and confirmed that there were multiple messages: ¿sample rack in lane 1 was rejected due to missing positional barcode at position 1¿.Technical support noted that the issue is most likely due to the operator not pushing the rack in position before loading the next rack.On (b)(6) 2026, the hologic field service engineer (fse) was dispatched and confirmed error in the logs.The fse removed and replaced the sample bay module and verified rack presence and barcode sensing in all eight lanes.

• Brand Name: PANTHER INSTRUMENT
• Common Device Name: HOLOGIC PANTHER, INSTRUMENT SYSTEM
• 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: amy holtgraver ; 10210 genetic center drive; san diego, CA 92121 ; 8584108236
• MDR Report Key: 24591021
• Report Number: 2024800-2026-00012
• Device Sequence Number: 21230908
• Product Code: OOI
• UDI-Device Identifier: 15420045504141
• UDI-Public: 15420045504141
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K171963
• 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): 03/13/2026

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?: Yes
• Device Catalogue Number: PRD-05490
• Device Lot Number: 929943
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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