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

Catalog Number PRD-06419

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 05/05/2022

Event Type  malfunction  

Event Description

Hologic field application specialist (fas) reported on behalf of customer a contamination event.Customer noticed the number of positives increased from a sars-cov-2 run.Wl# (b)(4) had 59 positives out of 247 samples.Customer used assay lot 317372 on the panther instrument sn (b)(4).Per fas communication with the customer, the positive samples were not reported out.Customer recognized a possible contamination and started cleaning.Customer confirmed that the source of contamination was the laboratory hood.Fas was on-site and helped clean the contaminated areas.The laboratory staff completed environmental swabs and cleaning.No additional contamination was found.

• 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: abel saluta ; 10210 genetic center drive; san diego, CA 92121 ; 8584108506
• MDR Report Key: 14568632
• MDR Text Key: 300806256
• Report Number: 2024800-2022-00354
• 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: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: PRD-06419
• Device Lot Number: 317372
• 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