MAUDE Adverse Event Report: HOLOGIC, INC. FUSION SARS COV-2/FLU/RSV; PANTHER FUSION SARS COV-2/FLU A/B/RSV ASSAY

Catalog Number	PRD-07400
Medical Device Problem Code	Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hologic technical support (ts) and product application support (pas) reviewed logs from 08/19/24 to 08/22/24 and confirmed that on wl 003394-20240819-14, 3 out of 38 samples produced positive flu b/sars-cov-2 results; from wl 003394-20240820-64, 6 out of 53 samples produced positive flu b/sars-cov-2 results; from on wl-003394-20240821-78, 6 out of 24 samples produced positive flu b/sars-cov-2 results.Ts reviewed the positive samples in question from the initial run and noted that all positive results for flu b and sars-cov-2 had >2000 rfu range with the threshold being 1000.Based on the curves, ts observed that the results appear to be false.The customer noted that this issue is recent, as they have been running the sars/flu a/b/rsv since the beginning of the year.Hologic completed a risk assessment and concluded that the risk of customer questioning results and/or the risk of false flu b positive result when a patient sample is sars-cov-2 positive is broadly acceptable.Hologic informed all quest sites about ctb-01273 that there is a potential erroneous influenza b virus (flu b) positive results when testing with the panther fusion sars-cov-2/flu a/b/rsv assay on the panther fusion system.Hologic implemented an update to the crosstalk correction algorithm of the panther fusion sars-cov-2/flu a/b/rsv assay software.Hologic confirmed that the software 7.2.7 version for panther fusion systems sn 2090003394 (08/28/24) and sn 2090000527 (08/29/24)were upgraded.H3 other text : other.
Event or Problem Description
On 08/22/2024, quest diagnostics customer site reported to hologic that they had false positive flu-b results across multiple worklists (wl) while using the sars/flu a/b/rsv assay (cartridge ln 887424) (ml 890419) on panther fusion instrument (sn (b)(6).Customer reported multiple flu b and sars-cov-2 dual positive results in the last few runs.Customer retested the associated sars-cov-2 and flu b dual positive samples on their other panther fusion instrument (b)(6), which resulted in sars-cov-2 positive and flu b negative results.

• Brand Name: FUSION SARS COV-2/FLU/RSV
• Common Device Name: PANTHER FUSION SARS COV-2/FLU A/B/RSV ASSAY
• 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 ; 8584108109
• MDR Report Key: 20263844
• Report Number: 2024800-2024-00014
• Device Sequence Number: 11354345
• Product Code: QOF
• UDI-Device Identifier: 15420045515352
• UDI-Public: 15420045515352
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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

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: PRD-07400
• Device Lot Number: 890419
• 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: 08/22/2024
• Initial Report FDA Received Date: 09/19/2024
• 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
• Patient Sex: Unknown