Description of Event or Problem · 1
TWO DAYS AFTER THE DATE OF EVENT THE LAY REPORTER, THE LAY PATIENTS SON, CONTACTED LIFESCAN (LFS) UK ALLEGING THAT THE PATIENTS ONE TOUCH METER WAS READING INACCURATELY ERRATIC. THE MEDICAL AFFAIRS SPECIALIST (MAS) SENT FOLLOW-UP QUESTIONS TO LFS UK AND RECEIVED ANSWERS 06 INCORPORATED IN THE FOLLOWING INFORMATION: THE PATIENT HAS "BRITTLE DIABETES". SHE TAKES NOVO RAPID INSULIN 4 TO 5 TIMES PER DAY; SHE TAKES EXTRA INSULIN DURING THE DAY DEPENDING ON HOW SHE FEELS. SHE ALSO TAKES LANTUS INSULIN BEFORE BEDTIME; SHE ASJUSTS HER DOSE BETWEEN 8 TO 21 UNITS DEPENDING ON HOW SHE IS FEELING. SHE TESTS HER BLOOD GLUCOSE EVERY HOUR. HOWEVER, SHE DID NOT RECALL THE SPECIFIC READINGS OBTAINED PRIOR TO 12:00 PM ON THE DATE OF EVENT. THE CUSTOMER SERVICE AGENT (CSA) NOTED THAT THE METER DATE AND TIME WERE NOT SET CORRECTLY IN THE METER. THEREFORE THE DATE AND TIME OF READINGS COULD NOT BE VERIFIED IN REVIEWING THE METER MEMORY. ON THE DATE OF EVENT THE PATIENT DID NOT TAKE PRE-BREAKFAST INSULIN. SHE ATE BREAKFAST AND TOOK 7.5 UNITS OF NOVA RAPID INSULIN AT APPROXIMATELY 10:00 AM. SHE OBTAINED A RESULT OF 22.0 MMOL/L ON THE REPORTED METER AT 12:00 PM WHILE HAVING NO SYMPTOMS OF HIGH OR LWO BLOOD GLUCOSE LEVEL. AFTER TESTING WITH THE METER, THE PATIENT TOOK NO ADDITIONAL INSULIN. SHE ATE EGG AND MAYONNAISE SANDWICHES AT APPROXIMATELY 12:30 PM AND WENT FOR A WALK. AFTER 20 MINUTES, DURING THE WALK, THE PATIENT FELT DIZZY AND "UNWELL". SHE DRANK A SUGAR DRINK SHE HAD WITH HER AND COLLAPSED. A WOMAN WALKING IN TH VILLAGE CALLED THE PATIENTS SON. HE REACHED THE PATIENT WITHIN LESS THAN ONE MINUTE. THE SON TESTED THE PATIENTS BLOOD GLUCOSE AND OBTAINED A RESULT OF 2.1 MMOL/L ON THE ONE TOUCH ULTRA METER, WHICH CORRELATED WITH THE PATIENTS SYMPTOMS. THE SON GAVE THE PATIENT A GLUCAGON INJECTION AND CALLED EMERGENCY SERVICES. EMTS STARTED AN IV DRIP AND TESTED THE PATIENTS BLOOD GLUCOSE LEVEL. A RESULT OF 7.6 MMOL/L WAS OBTAINED ON THE EMTS METER. THE PATIENT WAS TAKEN TO THE HOSPITAL AND RELEASED ON THE DAY AFTER EVENT DATE. THE CSA CONFIRMED THAT THE PATIENT USED CORRECT TESTING TECHNIQUE, THE METER WAS CODED CORRECTLY, AND THE TEST STRIPS WERE IN DATE. A CONTROL SOLUTION TEST WAS PERFORMED ON THE METER PRIOR TO THE SON CALLING LFS. THE CONTROL SOLUTION TEST RESULT WAS IN RANGE; HOWEVER, THE CONTROL SOLUTION WAS EXPIRED. THE METER, TEST STRIPS, AND CONTROL SOLUTIN WERE REPLACED. THE COMPLAINT IS REPORTED BECAUSE THE RESULT OF 22.0 MMOL/L OBTAINED ON THE LFS PRODUCT APPEARS TO HAVE BEEN INCORRECT. THE PATIENTS BLOOD GLUCOSE LEVEL WOULD NOT BE EXPECTED TO DECREASED FROM 22.0 TO 2.1 MMOL/L WITHIN 50 TO 60 MINUTES. THE PATIENT EXPERIENCED SYMPTOMATIC HYPOGLYCEMIA WHILE TAKING A WALK.