MAUDE Adverse Event Report: HOLOGIC, INC. APTIMA BV ASSAY; VAGINITIS AND BACTERIAL VAGINOSIS NUCLEIC ACID DETECTION SYSTEM

Catalog Number PRD-05186

Device Problem Erratic Results (4059)

Patient Problem Insufficient Information (4580)

Event Date 12/22/2022

Event Type  Injury  

Event Description

Customer reported one false negative aptima bv sample during lot-to-lot validation of assay lots 332571 and 328152 on panther instrument sn (b)(4).The sample in question was initially run in wl (b)(4) using assay lot 332571 and resulted negative.The sample amplified in two target regions, but based on the algorithm, it was determined the sample was negative.When retested in wl (b)(4) using assay lot 328152, the sample resulted positive.The initial negative result was reported out.Customer did not inform hologic of any results being amended or patient impact.

Manufacturer Narrative

Hologic reviewed logs and found no evidence of hardware or reagent preparation issues that could have contributed to questionable results.Hologic reviewed the curves for the initial test and retest and confirmed that the initial sample¿s amplification did not reach the threshold for positivity.Ts relayed this review to customer and explained the discrepancy was likely due to low target in the sample.The assay is performing as intended.Customer understood and was satisfied with the explanation.

• Brand Name: APTIMA BV ASSAY
• Type of Device: VAGINITIS AND BACTERIAL VAGINOSIS NUCLEIC ACID DETECTION SYSTEM
• 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: kyleigh jacobs ; 10210 genetic center drive; san diego, CA 92121 ; 8584108566
• MDR Report Key: 16214500
• MDR Text Key: 307788941
• Report Number: 2024800-2023-00005
• Device Sequence Number: 1
• Product Code: PQA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190452
• 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: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: PRD-05186
• Device Lot Number: 332571, 328152
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2022
• Initial Date FDA Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other