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 08/10/2022

Event Type  malfunction  

Manufacturer Narrative

Customer was informed on how to avoid contamination of negative controls.

Event Description

Customer reported false positives results were observed in negative control samples when running sars cov-2 assay on the panther instrument.Hologic technical support (ts) noted that these are internally prepared samples, but there is no information given on of the formulation (e.G.Water, specimen transport media etc.), or how they are prepared.The customer reported that 7/688 of their internally prepared negative control samples have returned a false positive result.There is no specific mention in the complaint of any confirmed clinical false positive cases.The alleged 7 false-positive negative control results couldn¿t be confirmed by hologic as the data files provided by the customer didn¿t line up exactly with what was reported by the customer in the complaint record.Hologic technical support (ts) noted that because the customer only believes they reported false-positive results by running negative controls, it is not 100% certain that false-positive results were reported out.Molecular application specialist (mas) contacted the customer discussed their workflow.Hologic review of worklist (b)(4) using master lot: 317372 showed 1 suspected false positive result.There is no known product impact to date.It was noted that several different master lots have been used where false positive results are suspected, therefore product is unlikely to be the cause.There is also no indication from the customer or technical support that the cause is product related.

• 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: 15204863
• MDR Text Key: 304976495
• Report Number: 2024800-2022-01083
• Device Sequence Number: 1
• Product Code: OJR
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• 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
• Date Manufacturer Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1