Description of Event or Problem · 0
THIS IS A LABELING ERROR. THIS EVENT DID NOT HARM A PATIENT/WAS NOT USED ON A PATIENT. THE AGE AND WEIGHT INPUT ARE IRRELEVANT. THIS SITE WAS GIVEN BRAND "DOSETEST" FENTANYL AND XYLAZINE TEST STRIPS AS APART OF SUBSTANCE USE HARM REDUCTION INITIATIVE. UPON EVALUATING THE PACKAGING, IT WAS FOUND THAT THE RESULTS SECTION ON THE PHYSICAL TEST KITS ARE NOT WHAT IS SHOWN FOR THE PRODUCT ON THE WEBSITE. THEY HAVE 2 DIFFERENT VERSIONS OF WHAT IS A POSITIVE OR INVALID RESULT. I HAVE CONTACTED THE COMPANY BY EMAIL AND SENT PHOTOS. THEY RESPONDED SAYING THEY HAVE "2 DIFFERENT VARIATIONS IN PRODUCTION RECENTLY". HOWEVER, THERE HAS BEEN NO COMMUNICATION WITH THE SITES THAT USE THIS PRODUCT THAT THERE WAS A CHANGE IN HOW TO READ THE RESULTS, OR WHEN THIS CHANGE OCCURRED, AND THERE IS NO DISCLAIMER ON THEIR WEBSITE. THEY ALSO STATED "ALL OF THE RESULTS AND INSTRUCTIONS ARE ON THE POUCH SO YOU DO NOT NEED TO REFERENCE ANY ONLINE INSTRUCTIONS." HOWEVER- THERE IS NO STATEMENT SAYING YOU CAN'T USE THE WEBSITE, AND THE WEBSITE CLEARLY LISTS INSTRUCTIONS UNDER THESE ALL IN ONE KITS, MAKING IT SEEM APPROPRIATE FOR CONSUMERS TO REFERENCE. WE ARE AWARE THIS IS NOT AN FDA APPROVED PRODUCT BUT BELIEVE THIS IS HIGHLY MISLEADING/CONFUSING FOR CONSUMERS AND COULD LEAD TO PATIENT HARM BECAUSE THEY ARE NOT PROVIDED WITH CLEAR INSTRUCTIONS ON HOW TO READ THE TEST STRIP RESULTS. WE HAVE NOTIFIED OTHER (B)(6) SITES THAT USE THIS BRAND OF TESTING KITS AS WELL AS THE (B)(6). I ATTACHED 2 PHOTOS BELOW OF THE CONTRADICTING RESULTS. ONE IS A SCREENSHOT FROM THE DOSETEST WEBSITE. THE OTHER IS A PHOTO OF OUR TESTING PACKAGES WE RECEIVED. OF NOTE: I AM A PHARMACY STUDENT, EMMA GILLILAND, REPORTING THIS ERROR ON BEHALF OF MY ROTATION SITE. THE CONTACT INFORMATION LISTED AT THE END OF THIS REPORT IS MY PRECEPTOR AND DIRECTOR OF THIS IHS SITE. REFERENCE REPORT MW5151073.