Description of Event or Problem · 1
IN 2005 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE ONE TOUCH ULTRA METER WOULD NOT POWER ON. THE MEDICAL AFFAIRS SPECIALIST CONTACTED THE PATIENT TO OBTAIN AND VERIFY INFORMATION. THE PATIENT REPORTED THAT DURING THE WEEK OF NOVEMBER 21, 2005 THE REPORTED METER WOULD NOT POWER ON. SINCE THAT TIME THE PATIENT HAS USED HER SISTER'S METER TO TEST HER BLOOD GLUCOSE LEVELS. THE PATIENT TESTS HER BLOOD GLUCOSE LEVELS THREE TIMES PER DAY. THE PATIENT TAKES HUMALIN INSULIN, 20 UNITS IN THE MORNING AND 10 UNITS THAT EVENING. THE PATIENT COULD NOT GIVE SPECIFIC RESULTS, BUT STATED HER BLOOD GLUCOSE LEVELS ARE 'SOMETIMES HIGH AND SOMETIMES LOW.' THE PATIENT REPORTED THAT ON A MORNING IN 2005 SHE EXPERIENCED SYMPTOMS OF FEELING WEAK AND INCREASED URINATION. THE PATIENT STATED THAT ON THAT MORNING SHE HAD NOT TAKEN HER INSULIN. THE PATIENT'S FAMILY MEMBER TOOK HER TO THE HOSPITAL, HER BLOOD GLUCOSE RESULT WAS TESTED TO BE GREATER THAN 400 MG/DL ON A ONE TOUCH ULTRA SMART METER, AND THE PATIENT WAS GIVEN INSULIN INTRAVENOUSLY. THE PATIENT STAYED IN THE EMERGENCY ROOM FOR SVERAL HOURS, WAS NOT ADMITTED TO THE HOSPITAL, AND WAS DISCHARGED WHEN HER BLOOD GLUCOSE LEVELS WERE APPROXIMATELY 100 MG/DL. THE PATIENT STATED HER PHYSICIAN HAS NOT ADJUSTED HER MEDICATION REGIMEN, AND THAT SHE IS FEELING 'LIKE HERSELF' TODAY. THE CUSTOMER CARE ADVOCATE DETERMINED DURING TROUBLESHOOTING TELEPHONE CALL THAT THE PATIENT HAD REPLACED THE BATTERY IN THE METER LESS THAN ONE YEAR AGO, THE BATTERY CONTACTS WERE IN GOOD CONDITION AND THE PATIENT WAS USING THE CORRECT TEST STRIPS. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THIS INCIDENT IS BEING REPORTED AS AN ADVERSE EVENT DUE TO METER NOT POWERING ON, THE PATIENT EXPERIENCED SYMPTOMS OF HYPERGLYCEMIA AND HAD TO RECEIVE INSULIN TREATMENT IN EMERGENCY ROOM.