Description of Event or Problem · 1
REPORTER EXPERIENCED ELEVATED BLOOD SUGAR AFTER USING A NOVO PEN3. THE FIRST 2 DAYS OF USING A INSULIN CARTRIDGE IN THE PEN, THEIR BLOOD SUGAR WAS NORMAL. ON THE THIRD DAY, REPORTER EXPERIENCED BLOOD SUGAR OVER 300. REPORTER CALLED NOVOLIN AND TOLD THEM THEY THOUGHT SOMETHING MUST BE WRONG WITH THE INSULIN. THEY SAID THEY WOULD REPLACE THE INSULIN CARTRIDGES AND THEY DID. REPORTER USED A CARTRIDGE FROM THE NEW PACKAGE AND THE SAME THING HAPPENED. REPORTER CALLED THEM BACK AND THE NURSE AT NOVOLIN AGAIN AND SHE TOLD THEM THAT IT WAS RPTR AND THAT REPORTER SHOULD HAVE BLOOD WORK TAKEN. REPORTER EXPLAINED THAT THEY WERE IN THE HOSP FOR CORONARY HEART DISEASE A SHORT TIME AGO AND THEY HAD BLOOD WORK TAKEN BEFORE THEIR SURGERY. REPORTER CALLED BACK AND ASKED TO SPEAK TO SOMEONE ELSE AND THIS NURSE ASKED THEM IF THEY TOLD THEM TO DO A FUNCTION TEST ON THE PEN. THEY NEVER TOLD REPORTER TO DO THIS TEST. REPORTER FOLLOWED HER INSTRUCTIONS AND FOUND OUT THAT THEIR PEN QUIT WORKING WHEN THE CARTRIDGE WAS HALF EMPTY. REPORTER TRIED TO REPORT THIS TO UPPER MANAGEMENT AND THEY JUST ROUTED THEIR CALL TO CUSTOMER SERVICE AND THEN TO PRODUCT SAFERY. REPORTER ASKED THEM TO REIMBURSE THEM FOR THEIR EXPENSES FOR 50 TEST STRIPS AND A VIAL OF INSULIN AND THEY INFORMED UPPER MANAGEMENT OF THIS PROBLEM WHEN REPORTER WAS ONLY SEEKING REIMBURSEMENT OF UNDER ONE HUNDRED DOLLARS. THEY ONLY REQUESTED TO LOOK AT THE PEN, AFTER THEIR LAST CALL WHICH REPORTER TOLD THEM THEY WERE GOING TO INFORM THE FDA BECAUSE THEY DIDN'T SEEM INTERESTED IN NOTIFYING ANYONE IN UPPER MANAGEMENT OF THIS PROBLEM.