FDA Adverse Event Malfunction Summary report: N

PANTHER FUSION SARS-COV-2 ASSAY PPR SOLUTION

MDR report key: 20446890 · Received October 14, 2024

Report

Report Number: 2024800-2024-00020
Event Type: Malfunction
Date Received: October 14, 2024
Date of Event: August 14, 2024
Manufacturer: HOLOGIC, INC.
Product Code: QJR
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

HOLOGIC REVIEWED LOGS PROVIDED BY THE CUSTOMER. HOLOGIC DID NOT IDENTIFY ANY HARDWARE OR REAGENT PREPARATION ISSUES AND DETERMINED THAT THE POSITIVE SAMPLE IN QUESTION EITHER WAS LOW TARGET OR WAS MISHANDLED/CONTAMINATED. THIS WAS RELAYED TO THE CUSTOMER AND THEY QUESTIONED HOW THAT COULD BE. A MOLECULAR APPLICATIONS SPECIALIST (MAS) RELAYED TO THEM THAT SINCE ALL THE PANEL SAMPLES WERE NEGATIVE, NO ISSUE WAS INDICATED WITH THE INSTRUMENT OR ASSAY. MAS ADVISED THE CUSTOMER TO PERFORM A THERMOCYCLER CLEAN MAINTENANCE. CUSTOMER HAD NO ADDITIONAL QUESTIONS. CUSTOMER WAS PERFORMING CORRELATION/VALIDATION STUDIES, SO RESULTS WERE NOT REPORTED OUT. AS PART OF EUA AGREEMENT, FDA REQUIRES ALL SARS-COV-2 ASSAY QUESTIONING RESULTS AND FALSE RESULTS (CONFIRMED OR NOT) COMPLAINTS TO BE REPORTED AS MALFUNCTION MDR.

Description of Event or Problem · 0

ON (B)(6), 2024, CUSTOMER REPORTED TO HOLOGIC THAT THEY OBTAINED DISCREPANT RESULTS DURING VALIDATION/CORRELATION STUDIES WITH THE LDT-SARS-COV-2 ASSAY (CARTRIDGE LOT 746919) ON THE PANTHER FUSION INSTRUMENT (SN (B)(6)). CUSTOMER CREATED A SAMPLE BY POOLING PREVIOUSLY NEGATIVE SAMPLES TOGETHER. THE SAMPLE WAS SARS-COV-2 POSITIVE WHEN TESTED ON (B)(6), 2024, IN LDT-SARS-COV-2 WORKLIST (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
360048	PANTHER FUSION SARS-COV-2 ASSAY PPR SOLUTION	REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID	QJR	HOLOGIC, INC.		896408V

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown