MAUDE Adverse Event Report: HOLOGIC, INC. PANTHER FUSION ADV/HMPV/RV ASSAY; IN-VITRO DIAGNOSTIC, PRODUCT CODE

Catalog Number	ASY-10186
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	Respiratory Tract Infection (2420)
Date of Event	09/25/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported they had dual positive samples (unknown number of samples) for rv and hmpv when running the adv/hmpv/rv assay on the panther-fusion.These dual positive samples had early rv cycle times associated with high viral content and late hmpv cycle times with a slow ramp up to positivity.Per the customer's procedure, they retested the dual positive results using a new aliquot of viral medium placed into a new stm tube.One sample that was originally dual rv and hmpv positive then hmpv retested as negative.Hologic technical support (ts) reviewed the customer panther logs.Hologic determined the customer results should not be compared as they are from different aliquots.The result discrepancy was likely to be due to a low target.Ts informed customer that there is a risk of hmpv or adv false positive result for samples containing a high rhinovirus viral content.A risk assessment was completed, and the overall risks associated with dual positive results is that the probability of incorrect results is remote and the consequences are neither severe nor life-threatening.Although the possibility of dual positive results is part of hologic's labeling, hologic update the labeling to clarify the possibility of dual positive results due to high viral content.

• Brand Name: PANTHER FUSION ADV/HMPV/RV ASSAY
• Common Device Name: IN-VITRO DIAGNOSTIC, PRODUCT CODE
• Manufacturer (Section D): HOLOGIC, INC.; 10210 genetic center dr.; san diego CA 92121
• MDR Report Key: 9221135
• Report Number: 2024800-2019-00014
• Device Sequence Number: 19546153
• Product Code: OCC
• UDI-Device Identifier: 15420045509290
• UDI-Public: 15420045509290
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K172629
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/22/2019

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
• Operator of Device: No Information
• Device Catalogue Number: ASY-10186
• Device Lot Number: 239559
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 10/22/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other