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

Catalog Number PRD-06419

Device Problem No Apparent Adverse Event (3189)

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

Event Date 06/23/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022, customer reported that they were still experiencing positive contamination after hologic serviced the customer¿s panther instrument sn (b)(4) on (b)(6) 2022.Because customer suspected that there was still contamination, customer discontinued the use of the instrument and decided to perform additional investigational testing.Customer then asked hologic to review logs for worklist (b)(4).Customer used assay lot 317818.The worklist contains 81 samples tested and 6 were positive.Hologic field service engineers (fse) went to the customer site, performed a full performance qualification (pq) on panther instrument sn (b)(4) and produced the expected results.Hologic concluded that the discrepant results may have potentially been due to sample mishandling, cross contamination, the presence of a low target, or target degradation due to handling and storage.Fse reported that the customer feels confident that the multiple cleanings have resolved the issue and has continued using the panther instrument.No product impact is known to date.A review of the logs did not reveal instrument issues.

• Brand Name: APTIMA SARS COV-2
• Type of Device: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• Manufacturer (Section D): HOLOGIC, INC.; 10210 genetic center drive; san diego CA 92121
• Manufacturer (Section G): HOLOGIC, INC.; 10210 genetic center drive; san diego CA 92121
• Manufacturer Contact: abel saluta ; 10210 genetic center drive; san diego, CA 92121 ; 8584108506
• MDR Report Key: 15078904
• MDR Text Key: 300649133
• Report Number: 2024800-2022-01067
• Device Sequence Number: 1
• Product Code: OJR
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: PRD-06419
• Device Lot Number: 317818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2022
• Initial Date FDA Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1