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

Catalog Number ASY-10186

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem Respiratory Tract Infection (2420)

Event Date 09/25/2019

Event Type  Injury  

Event 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
• Type of Device: IN-VITRO DIAGNOSTIC, PRODUCT CODE
• Manufacturer (Section D): HOLOGIC, INC.; 10210 genetic center dr.; san diego CA 92121
• Manufacturer (Section G): HOLOGIC, INC.; 10210 genetic center dr.; san diego CA 92121
• Manufacturer Contact: juliette busse ; 10210 genetic center dr.; san diego, CA 92121 ; 8584108799
• MDR Report Key: 9221135
• MDR Text Key: 169728286
• Report Number: 2024800-2019-00014
• Device Sequence Number: 1
• Product Code: OCC
• UDI-Device Identifier: 15420045509290
• UDI-Public: 15420045509290
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: No Information
• Device Catalogue Number: ASY-10186
• Device Lot Number: 239559
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/25/2019
• Initial Date FDA Received: 10/22/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other