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

Catalog Number PRD-05189

Device Problem Erratic Results (4059)

Patient Problem Insufficient Information (4580)

Event Date 11/30/2023

Event Type  Injury  

Event Description

On 12/08/2023, a customer reported to hologic that they had one discrepant acv/tv sample run on their panther fusion plus instrument.The sample was initially tested on (b)(6) 2023 using assay lot 884972 and resulted positive for trichomonas vaginalis (tv).The customer site has an internal protocol to retest any tv-positive samples.When the sample was retested on (b)(6) 2023 using assay lot 884972, the sample resulted negative for tv.The customer confirmed that the negative result was reported to the patient.There was no information provided by the customer about any patient impact or treatment provided to the patient.

Manufacturer Narrative

Hologic technical support (ts) reviewed the instrument logs.Both the initial and retest runs were valid and had no hardware or reagent preparation issues identified.In the first run, the sample in question was among several negative samples.Ts suggested the affected sample could have had low target or was mishandled.Customer understood the log review and reported no further issues.Hologic completed a risk assessment.No serious injury has been reported to hologic in association with this issue.The aptima cv/tv assay package insert limitations states that ¿results from the aptima cv/tv assay should be interpreted in conjunction with other clinical data available to the clinician.¿ in addition, the ¿[u]se of this assay is limited to personnel who have been trained in the procedure.Failure to follow the instructions given in this package insert may result in erroneous results.¿.

• Brand Name: APTIMA CV/TV 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: 18460524
• MDR Text Key: 332262983
• Report Number: 2024800-2024-00001
• Device Sequence Number: 1
• Product Code: PQA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190472
• 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: 01/05/2024

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-05189
• Device Lot Number: 884972
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2023
• Initial Date FDA Received: 01/05/2024
• 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