TARGET HCG URINE CONTROL SET

Description of Event or Problem

ON (B)(6) /2014 A POINT OF CARE TESTING USER AT (B)(6) MEDICAL CENTER,(B)(6) REPORTED URINE HCG QUALITY CONTROL RESULTS WERE TESTING OPPOSITE OF THEIR INTENDED REACTIONS. THE QC BOTTLES WERE RETESTED IN THE CLINICAL LABORATORY AND RESULTS CONFIRMED. REPORTED DEVIATION TO THE MANUFACTURER ON (B)(6) 2014. WE WERE INSTRUCTED TO RETURN THE KIT AND REPLACEMENT MATERIAL WOULD BE SHIPPED TO OUR FACILITY. ACCORDING TO THE MANUFACTURER THERE HAD BEEN NO OTHER INCIDENTS OF THIS NATURE REPORTED. ON (B)(6) 2014 ONE OF OUR OTHER FACILITIES, (B)(6) HOSPITAL EXPERIENCED THE SAME DEVIATION IN THE CLINICAL LABORATORY. THE TESTING WAS REPEATED AND RESULTS WERE CONFIRMED. THE MANUFACTURER WAS CONTACTED AGAIN. THE CONTACT PERSON STILL CLAIMED THAT NO OTHER INCIDENTS OF THIS KIND HAD BEEN REPORTED. REPLACEMENT KITS RECEIVED. ADDITIONAL LOT NUMBERS AVAILABLE ON SITE AT EACH FACILITY FOR QC TESTING, THESE LOTS WERE OBTAINING THE EXPECTED RESULTS. AS NO TIME WAS PT CARE IN JEOPARDY OR QC NOT PERFORMED. EVENT REAPPEARED AFTER REINTRODUCTION: #1 AND #2: YES.