Description of Event or Problem · 1
SKIN CARCINOMA [SKIN CANCER]; FEELING STRONG PAIN ON HAND'S BONE [PAIN IN EXTREMITY]; FEELING PAIN ON HER MOUTH OR TEETH [ORAL PAIN]; URINARY INFECTION [URINARY TRACT INFECTION]; INJECTION SITE REDNESS [INJECTION SITE ERYTHEMA]; INJECTION SITE BRUISING [INJECTION SITE HAEMATOMA]; BLOOD SUGAR LEVEL NOT STABILIZED [BLOOD GLUCOSE FLUCTUATION]; BLOOD SUGAR LEVEL WAS HIGHER THAN 300 MG/DL [BLOOD GLUCOSE INCREASED]. CASE DESCRIPTION: THIS SPONTANEOUS CASE FROM BRAZIL WAS REPORTED BY A CONSUMER, AS "INJECTION SPOT REDNESS AND AFTER A FEW TIMES THE REDNESS TURN INTO A BRUISE", "BLOOD SUGAR LEVEL IS NOT STABILIZED", "FEELING PAIN IN HER MOUTH OR TEETH", "URINARY INFECTION", "FEELING STRONG PAINS ON HER HAND'S BONE", "BLOOD SUGAR LEVEL WAS HIGHER THAN 300 MG/DL" (ALL EVENTS ARE NON-SERIOUS) AND "SKIN CARCINOMA" (SERIOUS EVENT). THE CASE CONCERNS A FEMALE PT TREATED WITH LEVEMIR FLEXPEN (INSULIN DETEMIR) AND OTHER SUSPECTED PROD NOVOMIX 30 FLEXPEN (DUAL-ACTING INSULIN ASPART) (START/STOP DATE OR ONGOING WAS NOT REPORTED) AND NOVOFINE 6 MM NEEDLE, FOR DIABETES MELLITUS. MEDICAL HISTORY INCLUDES TWO CAESAREAN SECTIONS IN 1977 AND 1979 WITHOUT COMPLICATION. FOUR YEARS AGO THE PT FELT STRONG PAINS ON HER HAND'S BONE AND AN EXAM SHOWED THAT HER BLOOD SUGAR LEVEL WAS HIGHER THAN 300 MG/DL, AND SHE HAD A URINARY INFECTION BUT SHE WAS NOT HOSPITALIZED. IN 2008, THE PT WAS ADMITTED TO THE HOSP FOR SURGERY DUE TO SKIN CARCINOMA. FROM FIVE MONTHS LATER, THE PT STARTED TO USE A NEW BATCH OF NOVOMIX 30 FLEXPENS, LEVEMIR FLEXPENS AND NOVOFINE NEEDLES. AFTER THE INJECTION THE PT NOTED THAT THE INJECTION SPOT GOT RED AND AFTER A FEW TIMES THE REDNESS TURNED INTO A BRUISE. THE PT WAS NOT DOING THE PLEAT IN THE INJECTION MOMENT DUE TO OBESITY. THE PT CHANGED THE INJECTION SPOT BETWEEN HER LEG AND ARM. THE INJECTION PROCEDURE WAS: SHE CLEANED HER HANDS AND THE INJECTION SPOT WITH COTTON AND ALCOHOL AND THEN LET IT DRY. SHE TOOK THE FLEXPENS AND THE NEEDLE'S CAP OFF, THEN SELECTED 20 UNITS AND TRIED TO DO THE PLEAT AND INJECT THE INSULIN SLOWLY. THE PT WAS AFRAID OF THIS BRUISE PROBLEM AND THAT HER BLOOD SUGAR LEVEL WAS NOT STABILIZED. EVERY TIME THE PT INJECTED THE INSULIN SHE FELT A LITTLE BIT ANXIOUS AND HER SKIN SHOOK AFTER THE INJECTION FOR A FEW SECONDS. SHE NOTED THAT AFTER THE THIRD INJECTION WITH THE SAME NEEDLE IT WAS EASY TO SEE A CUT. SHE DID NOT KNOW IF THE CUT HAPPENED WHEN SHE USED A NEW NEEDLE. SHE NEVER FELT PAIN ON INJECTION SPOT BUT IT ALWAYS GOT REDNESS. ON THE FOLLOWING MONTH, THE PT NOTED THAT THE FLEXPEN'S PUSH BUTTON WAS A LITTLE HARDER TO PUSH SO SHE TOOK THE NEEDLE OUT OF HER SKIN AND TRIED TO INJECT AGAIN BUT THEN NOTED THAT THE NEEDLE WAS TWISTED. ON AN UNK DATE, THE LAST BLOOD GLUCOSE TEST WAS 187 MG/DL AND AFTER MEAL 148 MG/DL. ON AN UNK DATE, THE PT WAS FEELING PAIN IN HER MOUTH OR TEETH BUT SHE DID NOT KNOW IF IT WAS INFECTION OR INFLAMMATION. THE PROD WAS TRANSPORTED IN HER PURSE WITHOUT REFRIGERATION. THE DR TOOK THE INSULIN FROM THE REFRIGERATOR AND SHE STORED THE PROD IN REFRIGERATOR TOO. SHE KEPT THE "IN USE" PROD IN A CLOSET IN THE KITCHEN WHERE THE SUNLIGHT DOES NOT REACH THE PLACE IS FRESH. SHE REC'D ORIENTATION ON HOW TO HANDLE THE PROD FROM A NURSE. SHE REUSES THE NEEDLE AND LET IT SET UP ON FLEXPEN. OUTCOME OF THE EVENT WAS NOT REPORTED. ACTION TAKEN TO THE SUSPECTED PRODS WAS NOT REPORTED. LEVEMIR FLEXPEN AND NOVOFINE NEEDLE HAS BEEN RETURNED FOR ANALYSIS. ON EIGHT DAYS LATER, THE PT WENT TO SEE HER DR. THE DR BELIEVED THAT THE PT WAS ADAPTING TO LEVEMIR HOWEVER, HE BELIEVED THAT THE BRUISES AND REDNESS COULD BE AN ALLERGIC REACTION. THE PT WAS ASKED TO CONTINUE USING THE PROD AND RETURN TO THE DR 15 DAYS LATER. RPTR'S CAUSALITY (ALL EVENTS AND PRODS): LEVEMIR FLEXPEN: POSSIBLE. NOVOMIX 30 FLEXPEN: POSSIBLE. NOVO NORDISK'S CAUSALITY (ALL EVENTS AND PRODS): LEVEMIR FLEXPEN: REPORTABLE. NOVOMIX 30 FLEXPEN: REPORTABLE. F/U INFO REC'D ON 21-OCT-2008 IDENTIFIED NOVOFINE 31G NEEDLE AS AN ADD'L SUSPECT PROD. COMMENT: CO COMMENT: ONLY VERY LIMITED INFO HAS BEEN PROVIDED REGARDING THE EVENT "SKIN CARCINOMA". NO TEMPORAL RELATIONSHIP BETWEEN THE EVENT AND SUSPECTED PRODS IS REPORTED, WHICH MAKES THE CAUSALITY ASSESSMENT DIFFICULT. THERE IS NO PLAUSIBLE MECHANISM TO IMPLICATE THE SUSPECTED DRUG.