FDA Adverse Event Malfunction Summary report: N

APTIMA SARS COV-2

MDR report key: 15469704 · Received September 23, 2022

Report

Report Number: 2024800-2022-01091
Event Type: Malfunction
Date Received: September 23, 2022
Date of Event: September 21, 2022
Report Date: September 22, 2022
Manufacturer: HOLOGIC, INC.
Product Code: QJR
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IT
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

HOLOGIC TECHNICAL SUPPORT (TS) REVIEWED LOGS AND CONFIRMED THE WL IN QUESTION HAD VALID CONTROLS AND SAMPLE RESULTS. THERE WAS A HARDWARE ISSUE IN THIS WL, BUT IT DID NOT AFFECT THE SAMPLE IN QUESTION. TS INFORMED CUSTOMER OF STATISTICAL VARIATION OF LOW TARGET SAMPLES POTENTIALLY CAUSING RESULT DISCREPANCIES. CUSTOMER UNDERSTOOD AND REPORTED NO FURTHER ISSUES. AS PART OF EUA AGREEMENT, FDA REQUIRES ALL APTIMA 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

CUSTOMER REPORTED ONE DISCREPANT RESULT IN SARS-COV-2 TMA RUN, WL 001337-20220920-02, USING ASSAY LOT 316590 ON PANTHER INSTRUMENT SN (B)(4). THE SAMPLE IN QUESTION WAS TESTED TWICE IN THE SAME SAMPLE RACK, LIKELY DUE TO OPERATOR ERROR INPUTTING DUPLICATE TEST ORDERS. BOTH THE NEGATIVE (305 RLUS) AND POSITIVE (676 RLUS) RESULTS WERE VALID. THE INFORMATION PROVIDED BY THE CUSTOMER WAS INSUFFICIENT TO CHARACTERIZE THE SAMPLE AS A CONFIRMED FALSE RESULT. THE LAB REPORTED THE NEGATIVE TEST RESULT, AND NO PATIENT TREATMENT WAS PROVIDED. THERE WERE NO ASSOCIATED OR REPORTED ADVERSE EVENTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
534010	APTIMA SARS COV-2	REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID	QJR	HOLOGIC, INC.		316590

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown