MAUDE Adverse Event Report: HOLOGIC INCORPORATED 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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/15/2021

Event Type  malfunction  

Event Description

Customer reported that they obtained incorrect results for third party external quality control samples (eqcs) during aptima sars-cov-2/flu assay validation on the panther instrument sn (b)(4).In addition, the customer noted that a sample from worklist 003070-20211119-23 that previously produced positive result using the aptima sars-cov-2 assay lot 307201, produced negative sars-cov-2 result during aptima sars-cov-2/flu assay validation using lot 303906.

Manufacturer Narrative

Hologic product application specialist (pas) review of the logs and did not find any reagent preparation issues or hardware issues.Of note, sample result produced rlu's between 565k - 738k, which is lower than what is typically seen in positive samples.Thus, per pas analysis, the sample may be low target sample, which may not repeat upon retesting, or the samples may possibly be contaminated.No product impact is known to date.

• 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 INCORPORATED; 10210 genetic center drive; san diego CA 92121
• Manufacturer (Section G): HOLOGIC INCORPORATED; 10210 genetic center drive; san diego CA 92121
• Manufacturer Contact: abel saluta ; 10210 genetic center drive; san diego, CA 92121 ; 8584108506
• MDR Report Key: 13083405
• MDR Text Key: 290069241
• Report Number: 2024800-2021-00079
• 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: 12/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: PRD-06815
• Device Lot Number: 303906
• 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