Description of Event or Problem · 1
ON (B)(6) 2013, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING SHE HAD BEEN GETTING ELEVATED BLOOD GLUCOSE READINGS OF "15.3 AND 19.3 MMOL/L" (275 AND 347 MG/DL) ON THE ONETOUCH VERIO IQ METER. THIS COMPLAINT IS CLASSIFIED BASED ON THE INITIAL CUSTOMER CARE ADVOCATE DOCUMENTATION AND THE FOLLOW-UP INFORMATION OBTAINED ON (B)(6) 2013. THE PATIENT TESTS HER BLOOD GLUCOSE 4 TIMES PER DAY, ONCE BEFORE EACH MEAL AND ONCE AGAIN BEFORE BEDTIME. THE PATIENT TAKES A SET OF AMOUNT OF HUMALOG AND LANTUS EACH DAY (11 UNITS OF HUMALOG WITH EACH MEAL AND 43 UNITS OF LANTUS BEFORE GOING TO BED). DURING THE PERIOD WHEN HER BLOOD GLUCOSE WAS ELEVATED PER THE LFS METER, THE PATIENT'S DOCTOR WAS GRADUALLY INCREASING HER LANTUS INSULIN REGIMEN FROM 34 UNITS TO 43 UNITS BEFORE BEDTIME. SOMETIME AFTER THE INSULIN REGIMEN CHANGE, THE PATIENT REPORTED HAD SYMPTOMS DESCRIBED AS "SWEATY, SICK TO STOMACH". THERE WERE IN REPORTED BLOOD GLUCOSE READING ON THE LFS DEVICE BEFORE AND DURING THE ALLEGED INCIDENT. THE PATIENT CLAIMED SHE FELT HER BLOOD GLUCOSE WAS LOW AND WAS ABLE TO ADMINISTERED SELF TREATMENT WITH FOOD AND DRINK. THERE WAS NO FURTHER HCP REQUIRED MEDICAL INTERVENTION AFTER THE SELF TREATMENT. THE PATIENT STATED SHE HADN'T SKIPPED ANY MEALS PRIOR TO THE INCIDENT IN QUESTION. IN ADDITION, THERE WAS NO UNPLANNED STRENUOUS ACTIVITY PRIOR TO THE AFOREMENTIONED SYMPTOMS. DURING TROUBLESHOOTING, THE PATIENT CONFIRMED SHE WAS COMPARING THE ELEVATED READING TO NORMAL READING/FEELING AT THE TIME OF CONCERN. THE UNIT OF MEASUREMENT WAS CORRECTLY SET. THERE WAS NO CONTROL SOLUTION AT THE TIME TO PERFORM A QUALITY TEST. THE TEST STRIPS WERE WITHIN THE DISCARD DATE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT HAD SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE ALLEGED ELEVATED BLOOD GLUCOSE BEGAN.