QUANTISAL

Additional Manufacturer Narrative

ALTHOUGH THIS INCIDENT OCCURRED IN (B)(6), UNDER MIR . IMMUNALYSIS ASSESSED IT AS MDR REPORTABLE AS THE SAME SKU (QS-0025) IS MARKETED IN THE US. INVESTIGATION IS ONGOING AND FOLLOW UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED ON 18-NOV-2020, THAT A PATIENT UNDERWENT WORKPLACE DRUG TESTING ON (B)(6) 2020, WITH A QUANTISAL¿ ORAL FLUID COLLECTION DEVICE (PART # QS-0025, LOT #UNKNOWN) AND SUFFERED AN ALLERGIC REACTION. INITIALLY, THE EVENT WAS ASSESSED AS NON-REPORTABLE, AS THEIR WAS NO MENTION OF MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 23-NOV-2020 (AWARENESS DATE), INDICATING THE DONOR'S ALLERGIC REACTION REQUIRED CONTACT WITH THEIR DERMATOLOGIST AND INVOLVED THE DONOR EXPERIENCING A SWOLLEN EYELID, ROSACEA OF THE EYES, AND COMPLETE NUMBNESS IN THE AREA BETWEEN THE UPPER LIP AND NOSE. DONOR CONTACT WITH THEIR DERMATOLOGIST WAS MADE THE DAY AFTER THE INCIDENT, ON (B)(6) 2020. DONOR MENTIONED SUSPICION OF QUANTISAL AS THE CAUSE OF THE ALLERGIC REACTION. HOWEVER, DONOR MENTIONED THAT THEY ARE ALLERGIC TO MANY THINGS. THE DONOR'S SYMPTOMS SUBSIDED AND EVENTUALLY DISAPPEARED. DONOR FULLY RECOVERED AND NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. IN AN ABUNDANCE OF CAUTION, IT WAS DECIDED TO REPORT THIS INCIDENT AS AN MDR.