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

Catalog Number	PRD-07400 / ASY-16066
Medical Device Problem Code	Device Contaminated at the User Facility (4064)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hologic technical support (ts) reviewed both worklists and noted no hardware issues.Customer was worried about residual contamination from a previous case so ts advised the customer to perform monthly maintenance and run one rack of empty lysis tubes.Customer followed the advice and the empty lysis tubes resulted as negative which indicated no residual contamination.Hologic field application specialist advised the customer to not touch the aluminum foil of the penetrable caps with potentially contaminated gloves.Ts informed the customer that touchpoint contamination of the pierceable caps was likely the cause of the issue.Customer retested the now negative resulting tubes again and obtained a negative result.Customer then retested the sample in the same tube that produced the positive result but with a new pierceable cap and obtained a negative result.Customer confirmed local contamination was likely on the pierceable cap due to these results.As part of eua agreement, fda requires all aptima sars-cov-2 assay questioning results and false results (confirmed or not) complaints to be reported as malfunction mdr.H3 other text : other.
Event or Problem Description
Customer performed one sars/flua/b/rsv run, wl: 000238-20230621-03 ((b)(62023), using assay lot 343968 on panther fusion instrument sn (b)(6) which had 2 questioning samples.Customer retested 2 initially positive results (wl: 000238-20230619-07 ((b)(6)2023)) using the same sample tube with a new pierceable cap, new sample aliquot, and same assay lot and obtained subsequent negative results for both samples (wl: 000238-20230621-03 ((b)(6)2023).The information provided by the customer was insufficient to characterize any sample as a confirmed false result.Customer confirmed that only the subsequent negative result was reported out.Customer did not note having information if the patient received treatment based on the reported results.There were no associated adverse events.

• Brand Name: PANTHER FUSION SARS-COV-2/FLU A/B/RSV ASSAY
• Common Device Name: FUSION SARS COV-2/FLU/RSV
• 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: geovan rich ; 10210 genetic center drive; san diego, CA 92121 ; 8584108938
• MDR Report Key: 17219474
• Report Number: 2024800-2023-00013
• Device Sequence Number: 16899695
• Product Code: QOF
• UDI-Device Identifier: 15420045515352
• UDI-Public: 15420045515352
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K222736
• 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): 06/26/2023

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-07400 / ASY-16066
• Device Lot Number: 343968
• 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: 06/21/2023
• Initial Report FDA Received Date: 06/28/2023
• 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
• Patient Sex: Unknown