MAUDE Adverse Event Report: HOLOGIC INC. PANTHER FUSION ADV/HMPV/RV ASSAY; RESPIRATORY VIRUS PANEL NUCLEIC ACID ASSAY SYSTEM

Device Problem False Positive Result (1227)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Respiratory virus panel by hologic panther fusion generates false positive hmpv results especially if strong rhinovirus result.We started using test in (b)(6) 2021.In 3 months, we have reported the problem multiple times to hologic, without resolution.It leads to frequent retesting, manual corrections, retesting on other platforms.All but one of the hmpv positives (i.E.38 of 39) have been false positives.We think it is an instrument issue, as older instruments on which the test was fda cleared, do not see this problem.Fda safety report id# (b)(4).

• Brand Name: PANTHER FUSION ADV/HMPV/RV ASSAY
• Type of Device: RESPIRATORY VIRUS PANEL NUCLEIC ACID ASSAY SYSTEM
• Manufacturer (Section D): HOLOGIC INC.
• MDR Report Key: 12432663
• MDR Text Key: 270489269
• Report Number: MW5103733
• Device Sequence Number: 1
• Product Code: OCC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/01/2021

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 Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/03/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1