MAUDE Adverse Event Report: HOLOGIC INCORPORATED APTIMA SARS-COV-2 ASSAY; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Catalog Number PRD-06419

Device Problem Device Contaminated at the User Facility (4064)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/09/2021

Event Type  malfunction  

Manufacturer Narrative

Hologic product applications specialist (pas) reviewed the logs for the specimens in question and noted they looked like true amplification.Hologic customer product support (cps) reviewed all available data and concluded all specimen ids provided by the customer appear as true amplification.Additionally, two specific worklists had much higher positivity rates than adjacent worklists; positives occurred in clusters, which was indicative of potential cross-contamination.Field applications specialist (fas) went onsite and assisted with multiple lab cleanings.As a precaution the thermocycler was replaced by a field service engineer (fse).After replacing the thermocycler and further decontaminated the lab, the customer did not report any further issue.Hologic and fda met on (b)(6) 2021, regarding how to report all "false/discrepant/questioning results" complaints for the aptima and panther fusion sars-cov-2 assays (panther fusion sars-cov-2 (b)(4) aptima sars-cov-2 (b)(4) and aptima sars-cov-2/flu (b)(4).Fda clarified that as part of the conditions for the emergency use authorization of sars-cov-2 assays, manufacturers are required to track adverse events including any occurrence of "false/discrepant/questioning results", confirmed or unconfirmed, and report to fda in accordance with 21 cfr part 803.Hologic, retrospectively is reporting complaints initiated from (b)(6) 2020 to present.This complaint where a customer provided two months' worth of logs containing 32 worklists (wls) is from 18 months ago.At the time of the event, hologic concluded that the issue was possibly due to cross-contamination.Hologic is electing to submit a single mdr for this issue as the information the customer provided does not enable hologic to make a decision on potential discrepant samples.

Event Description

Customer reported suspecting false positive results when running sars-cov-2 tma assays on panther fusion instrument sn (b)(4).Customer provided a list of suspect specimen ids and returned logs from the affected worklists.Hologic product applications specialist (pas) and customer product support (cps) reviewed all available data, including two months' worth of logs to identify any potential causes for this trend.The information provided by the customer was insufficient to characterize any sample as a confirmed false result.As results were released prior to identifying the contamination, a risk assessment was performed and deemed as far as possible.The customer reviewed affected results, including retesting positives from the affected worklists, and they amended results where appropriate.

• Brand Name: APTIMA SARS-COV-2 ASSAY
• Type of Device: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• Manufacturer (Section D): HOLOGIC INCORPORATED; 10210 genetic center drive; san diego CA 92121
• Manufacturer (Section G): HOLOGIC INCORPORATED; 10210 genetic center drive; san diego CA 92121
• Manufacturer Contact: kyleigh jacobs ; 10210 genetic center drive; san diego, CA 92121 ; 8584108566
• MDR Report Key: 15243180
• MDR Text Key: 301819023
• Report Number: 2024800-2022-00686
• Device Sequence Number: 1
• Product Code: QJR
• 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: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: PRD-06419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1