FDA Adverse Event Injury Summary report: N

APTIMA HPV SCREENING ASSAY

MDR report key: 22124469 · Received June 2, 2025

Report

Report Number: 2024800-2025-00032
Event Type: Injury
Date Received: June 2, 2025
Date of Event: May 7, 2025
Report Date: June 2, 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 AVAILABLE LOGS FOR BOTH RETEST WORKLIST (B)(6) AND NOTED NO HARDWARE, SOFTWARE, OR CONTAMINATION ISSUES. TS INDICATED THAT THE ISSUE WAS MOST LIKELY DUE TO LOW TARGET OR SAMPLE MISHANDLING. HOLOGIC COMPLETED A RISK ASSESSMENT. THERE IS NO PRODUCT IMPACT. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

Description of Event or Problem · 0

ON 5/7/25, A CUSTOMER REPORTED TO HOLOGIC RECEIVING DISCREPANT RESULTS USING THE APTIMA HPV (HUMAN PAPILLOMAVIRUS) ASSAY MASTER LOT 908328 ON THE PANTHER INSTRUMENT SN# (B)(6). SAMPLE IDS # (B)(6) WAS PART OF A CLUSTER AND INITIALLY RESULTED HPV POSITIVE (HPV WORKLIST NOT PROVIDED). PER THE CUSTOMER¿S LAB SOP, IF THERE IS A CLUSTER OF THREE HPV POSITIVES CONTAINING RESULTS WITH AN S/CO (SIGNAL-TO-CUTOFF) VALUE < 5, THE SAMPLES WITH S/CO<5 WILL BE RETESTED, AND THE RETESTED RESULT WILL BE REPORTED OUT. UPON RETEST, SAMPLE ID # (B)(6) RESULTED HPV NEGATIVE, AND THIS RESULT WAS REPORTED OUT. 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
619247	APTIMA HPV SCREENING ASSAY	KIT, RNA DETECTION, HUMAN PAPILLOMAVIRUS	OYB	HOLOGIC, INC.		908328	15420045500051

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Other