ORE-100

Additional Manufacturer Narrative

VERBALLY PROVIDED COMPLAINT TO MANUFACTURER (DNA GENOTEK) OIN (B)(6) 2022. DETAILS OF COMPLAINT FORWARDED TO MANUFACTURER ON 19JAN2022.

Description of Event or Problem

AN INDIVIDUAL, (B)(6) STUDENT, BEING TESTED USING THE ORE-100 COLLECTION DEVICE FOR USE WITH THE CLARIFI COVID-19 TEST KIT ON (B)(6) 2022 INGESTED THE STABILIZATION SOLUTION WITHIN THE COLLECTION TUBE. THE COLLECTION OF THE STUDENT'S SAMPLE WAS DONE IN THE PRESENCE OF A SCHOOL NURSE, EMT, AND HEALTH DEPARTMENT HEALTH EDUCATOR. THE STUDENT HAD BEEN INSTRUCTED ON HOW TO USE THE COLLECTION DEVICE, AND HAD COMPLETED PRIOR SALIVA COLLECTIONS USING THE ORE-100 DEVICE WITHOUT INCIDENT. THE SUSPECT MEDICAL DEVICE, ORE-100, IS USED TO COLLECT SALIVA FOR THE CLARIFI COVID-19 TEST KIT [EUA(B)(4)]. ORE-100 IS MANUFACTURED BY DNA GENOTEK AND IS INCLUDED IN THE CLARIFI COVID-19 TEST KIT MANUFACTURED BY QUADRANT BIOSCIENCES AS THE DEVICE FOR COLLECTING SALIVA SPECIMENS FOR TESTING THE CLARIFI TEST KIT. ON (B)(6) 2022, AN INDIVIDUAL PARTICIPATING IN A CLARIFI COVID-19 TESTING IN A SCHOOL SETTING, INGESTED THE STABILIZATION SOLUTION WITHIN THE COLLECTION TUBE OF THE DEVICE. STAFF AT THE TESTING SITE PROVIDED THE INDIVIDUAL SMALL AMOUNTS OF WATER AND DID NOT INDUCE VOMITING BASED ON THE RECOMMENDATIONS OF NEW YORK STATE POISON CONTROL CENTER. THE INDIVIDUAL CONTINUED TO BE OBSERVED BY STAFF. THE INDIVIDUAL LATER COMPLAINED OF A STOMACH ACHE WHICH PROMPTED AN EMERGENCY MEDICAL TECHNICIAN (EMT) TO ADVISE THAT THE INDIVIDUAL BE TAKEN TO THE LOCAL EMERGENCY ROOM. BASED ON THE INFORMATION PROVIDED AND MANUFACTURE'S SAFETY DATA SHEET (SDS), AT THE EMERGENCY ROOM THE INDIVIDUAL WAS AGAIN PROVIDED SMALL AMOUNTS OF WATER AND OBSERVED; NO TREATMENT WAS REQUIRED. A FOLLOW-UP WAS PERFORMED THE NEXT DAY BY THE LOCAL HEALTH DEPARTMENT, THE PARENT OF THE INDIVIDUAL INDICATED THERE WAS NOT A CONTINUATION OF DISCOMFORT BEYOND WHAT WAS EXPERIENCED ON (B)(6) 2022. THIS SUBMISSION IS BEING MADE OUT OF AN ABUNDANCE OF CAUTION, BECAUSE MEDICAL INTERVENTION OCCURRED. IT IS NOT KNOWN WHY THE CHILD FAILED TO FOLLOW THE SCHOOL STAFF'S INSTRUCTIONS ON HOW TO TAKE THE SALIVA SAMPLE ON THIS PARTICULAR TEST, AND THE POTENTIAL FOR ANY DEGREE OF HARM CAUSED BY INGESTION OF THE QUANTITY OF SOLUTION IN THE TUBE IS NOT KNOWN WITH CERTAINTY. THIS MATERIAL IS NOT CONSIDERED HAZARDOUS BY THE OSHA HAZARD COMMUNICATION STANDARD (29 CFR 1910.1200). WITH RESPECT TO INGESTION, THE SAFETY DATA SHEET STATES THAT NO KNOWN SIGNIFICANT EFFECTS OR CRITICAL HAZARDS. HTTPS://DNAGENOTEK.COM/US/PDF/PD-MSDS-00095.PDF.