FDA Adverse Event Injury Summary report: N

APTIMA HPV SCREENING ASSAY

MDR report key: 22080699 · Received May 23, 2025

Report

Report Number: 2024800-2025-00020
Event Type: Injury
Date Received: May 23, 2025
Date of Event: March 3, 2025
Report Date: May 23, 2025
Manufacturer: HOLOGIC, INC.
Product Code: OYB
UDI-DI: 15420045500051
PMA / PMN Number: P100042
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NJ, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

HOLOGIC TECHNICAL SUPPORT (TS) REVIEWED ALL OF WORKLISTS AND NOTED NO HARDWARE OR REAGENT PREPARATION ISSUES. SUSPECTED POTENTIAL SAMPLE MISHANDLING OR LOW TARGET SAMPLES. HOLOGIC PERFORMED A RISK ASSESSMENT AND NOTED NO PRODUCT IMPACT. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS ISSUE.

Description of Event or Problem · 0

ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC RECEIVING DISCREPANT RESULTS USING THE APTIMA HPV (HUMAN PAPILLOMAVIRUS) ASSAY MASTER LOT 908328 ON PANTHER PLUS INSTRUMENT SN (B)(6). SAMPLE ID (B)(6) WAS PART OF A CLUSTER AND INITIALLY RESULTED HPV POSITIVE ON HPV WL-010823-20250302-33. PER THE CUSTOMER¿S LAB SOP, IF THERE IS A CLUSTER OF THREE HPV POSITIVE RESULTS WITH AN S/CO (SIGNAL-TO-CUTOFF) VALUE < 5, THESE SAMPLES WILL BE RETESTED, AND THE RETESTED RESULT WILL BE REPORTED OUT. UPON RETEST, SAMPLE ID (B)(6) RESULTED HPV NEGATIVE ON HPV WL-010793-20250303-07. NO PATIENT TREATMENT INFORMATION WAS PROVIDED BY THE CUSTOMER. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2321007	APTIMA HPV SCREENING ASSAY	KIT, RNA DETECTION, HUMAN PAPILLOMAVIRUS	OYB	HOLOGIC, INC.		908328	15420045500051

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Other