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

Catalog Number PRD-06419

Device Problem Off-Label Use (1494)

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

Event Date 05/03/2022

Event Type  malfunction  

Event Description

Customer reported they had reported out the results of a few samples that were collected in dlt which had expired on april 30-2022.The samples were tested with the sars-cov-2 tma assay on the panther instrument sn (b)(4).Per the customer's pathologist's advice, customer would append a comment: specimen collection device expired on 4/30/2022 and interpret results accordingly.Hologic technical support (ts) requested customer for more information such as sample id and logs for review, but customer was not interested in providing them.Customer stated that the results had been amended and no further action was required from hologic.

Manufacturer Narrative

Hologic customer product support (cps) was unable to perform the risk assessment and quality was unable to perform the mdr assessment since customer did not want to provide the logs for review.

• 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: 14579937
• MDR Text Key: 293312358
• Report Number: 2024800-2022-00384
• 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: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• 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