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

Model Number	BV ASSAY, APTIMA, 100T, IVD
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, a customer reported discrepant results to hologic for the aptima bacterial vaginosis (bv) assay from, pn asy-11550 lot number 318661.Initial run results indicate a negative bv result.Retest results indicate a bv positive result.Per customer request, hologic reviewed the logs and notified customer of potentially affected samples.The customer retested the samples and identified two samples that were discordant.The customer indicated that they corrected the report for these specimens to bv positive.There is no indication that an adverse event occurred (the patient was impacted) due to the incorrect result.Review of customer data by hologic noted that previous abv runs had the ¿cce¿ flag, which is a calibration channel error.Per aw-20220-001, rev.001, the panther/panther fusion operator¿s manual indicates to contact hologic technical support when they receive the ¿cce¿ error code.The issue was likely caused by debris in the rtf.Root cause investigation is in process.
Event or Problem Description
See h10.
Event or Problem Description
Follow-up report.See section h10.
Additional Manufacturer Narrative
The following is a resubmission that was initially submitted as a follow up mdr (2024800-2022-01070) on 08/31/2022 by hologic.The field service engineer (fse) during servicing of the instrument found debris on the third position of the hex rtf.The fse could not identify where the debris originated from and how it ended up on the hex rtf lens.Fse described the debris as sticky and spongy and discarded it during servicing.The probability of harm is remote as the debris appeared on only one out of the five positions.Over the 2.5 months, only eleven samples were identified of being in position 3 and being read by the compromised hex rtf: 8 bv samples and 3 qhbv samples.Customer retested these 11 samples and obtained concordant results for the 3 hbv samples.Thus, there is no risk of incorrect hbv results due to this issue.The results of two of the 8 bv retested samples were discordant.The customer indicated that they corrected the report for these specimens to bv positive.There was no indication that an adverse event occurred due to these initial incorrect results.
Additional Manufacturer Narrative
Section b5 stated "follow-up report.See section h10." when it should have referenced section h11.
Event or Problem Description
See section h11.

• Brand Name: APTIMA BV ASSAY
• Common Device Name: 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: 15089973
• Report Number: 2024800-2022-01070
• Device Sequence Number: 5101789
• Product Code: PQA
• UDI-Device Identifier: 15420045512023
• UDI-Public: 15420045512023
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/19/2024

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 Model Number: BV ASSAY, APTIMA, 100T, IVD
• Device Catalogue Number: ASY-11550
• Device Lot Number: 318661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2022
• Supplement Date Received by Manufacturer: 06/23/2022; Not provided; Not provided
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 08/31/2022; 07/17/2024; 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown