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

Catalog Number PRD-06419

Device Problem Erratic Results (4059)

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

Event Date 10/06/2020

Event Type  malfunction  

Manufacturer Narrative

Hologic product applications specialist (pas) reviewed logs and found some negative samples had rlus in the 400-500 range, as well as lower positives (500-800 rlus) and some clusters of positives in this wl.Pas found evidence of kit preparation mishandling and advised to clean the workspaces and common touchpoints.Customer informed that they traced the spike in positivity in the wl in question to one operator preparing reagent kits on october 5th and 6th.No further issues reported.Hologic and fda met on october 29, 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 (eua(b)(4)), aptima sars-cov-2 (eua(b)(4)), and aptima sars-cov-2/flu (eua(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 march 16, 2020 to present.

Event Description

Hologic product application specialist (pas) reported on behalf of customer an increased positivity rate on their sars-cov-2 tma runs on panther instrument sn (b)(4).They were unsure if there was a spike in sars-cov-2 in the area or if the issue was due to the air conditioner unit above their sars samples.All environmental swabs on the instrument were negative.Pas reviewed wl 002976-20201005-19 to identify any potential contamination, which had 50 positives out of 248 samples.The information provided by the customer was insufficient to characterize any sample as a confirmed false result.There was no indication of results being reported to patients.Lot number of the assay not provided.

• 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: 15801867
• MDR Text Key: 307196481
• Report Number: 2024800-2022-00690
• 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: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• 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