FDA Adverse Event Malfunction Summary report: N

CHECK-IT

MDR report key: 13308817 · Received January 20, 2022

Report

Report Number: 3016521623-2022-00005
Event Type: Malfunction
Date Received: January 20, 2022
Date of Event: January 2, 2022
Report Date: January 20, 2022
Manufacturer: LUCIRA HEALTH, INC.
Product Code: QJR
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

PRODUCT WAS NOT RETURNED. A DHR REVIEW OF THE ASSOCIATED KIT LOT NUMBER (K07A110812214M5) WERE COMPLETED, AND 0 DISCREPANCIES WERE FOUND. A REVIEW OF EXISTING CAPA, SCAR AND NCMRS WERE COMPLETED AND THERE ARE NO PRIOR RECORDS RELATED TO FALSE POSITIVE FAILURE MODE FOR THIS LOT. SAMPLE VIAL LOT DHRS: 2111153, 2111155, 2111123, 2110274, 2111261 (INTERNAL LOT #S RDL519, 210762-2IM, RDL517, RDL520, RDL518, RDL510, RDL471, 210762-2GT) TEST LOT DHRS: 2111224, 2111376 , 2111294, 2111197, 2111210, 2111274, 2111173, 2111211, 2111292, 2111273 (INTERNAL LOT #S 210762-17I, 210762-21C, 210762-18N, 210762-16P, 210762-16W, 210762-18K , 210762-15Z, 210762-17E, 210762-18Z, 210762-19A, 210762-18R, 210762-18W, 210762-19B, 210762-18L, 210762-18M, 210762-17B, 210762-18V, 210762-16Q). FALSE POSITIVE IS A KNOWN POSSIBLE OUTCOME FOR A VERY SMALL PERCENTAGE OF CASES. ROOT CAUSE CANNOT BE DETERMINED BASED ON THE INFORMATION AVAILABLE. POTENTIAL ROOT CAUSES INCLUDE BUT ARE NOT LIMITED TO: ENVIRONMENTAL CONTAMINATION, LOW VIRAL LOAD, AND/OR DEVICE FAILURE. THIS DEVICE IS MARKETED UNDER EUA (B)(4) CHECK-IT.

Description of Event or Problem · 0

ONE DEVICE REPORTED AS HAVING A FALSE POSITIVE RESULT. COMPLAINANT PERFORMED AN ADDITIONAL PCR TEST WITH A NEGATIVE RESULT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
484917	CHECK-IT	COVID-19 TEST KIT	QJR	LUCIRA HEALTH, INC.		K07A110812214M5

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown	Other