MAUDE Adverse Event Report: HOLOGIC, INC. APTIMA SARS-COV-2/FLU MULTIPLEX ASSAY; COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES

Catalog Number PRD-06815

Device Problem Erratic Results (4059)

Patient Problem Insufficient Information (4580)

Event Date 01/12/2024

Event Type  malfunction  

Manufacturer Narrative

Hologic technical support (ts) offered to review the logs, but the customer declined.Ts explained to the customer that hologic does not provide any instructions for releasing results.The customer decided to release the positive result after reading through the sars/flu package insert with their medical director.Hologic completed a risk assessment.No patient impact has been reported to hologic in association with this issue.The aptima sars-cov-2/flu assay package insert limitations states that ¿clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status.¿ in addition, therapy for sars-cov-2 is administered in accordance with symptoms and patient risk factors; risk from standard treatment of sars-cov-2 is considered low.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.

Event Description

On (b)(6) 2024, a customer reported to hologic that they had one discrepant sars/flu sample run on their panther fusion plus instrument (sn (b)(6)).The same sample tube was accidentally tested twice, resulting sars positive/flu negative the first time and sars negative/flu negative the second time.The customer did not provide any logs, test dates, sample ids, lot numbers, etc.To hologic as they only wanted instructions on which result to report.After reading through the sars-cov-2/flu assay package insert with their medical director, the customer decided to release the sars positive/flu negative result.The information provided by the customer was insufficient to characterize the sample as a confirmed false result.There is no patient impact known to date.The customer has not provided any treatment information to hologic.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.

• Brand Name: APTIMA SARS-COV-2/FLU MULTIPLEX ASSAY
• Type of Device: COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES
• 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: kyleigh jacobs ; 10210 genetic center drive; san diego, CA 92121 ; 8584108566
• MDR Report Key: 18651429
• MDR Text Key: 334671216
• Report Number: 2024800-2024-00002
• Device Sequence Number: 1
• Product Code: QLT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: PRD-06815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1