Description of Event or Problem · 1
ON (B)(6) 2013, A LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) IN (B)(4) ALLEGING HIS ONETOUCH ULTRASMART METER HAD A DISPLAY ISSUE ¿SOMETIMES IT WORKED AND SOMETIMES IT DIDN¿T¿. HE REPORTEDLY HAD TO TEST 10 TIMES BEFORE GETTING A READING. THIS COMPLIANT WAS DOCUMENTED USING THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED 1 WEEKS PRIOR TO CONTACTING LFS THE ALLEGED ISSUE FIRST OCCURRED. THE PATIENT REPORTED USING A COMBINATION OF MEDICATIONS INCLUDING METFORMIN, 32 UNITS OF LANTUS INSULIN TWICE A DAY AND HUMALOG INSULIN. THE PATIENT REPORTED A COUPLE OF WEEKS PRIOR TO CONTACTING LFS THE PATIENT HAD BEEN INCREASING HIS USUAL DOSE OF HUMALOG TO 26 UNITS 4 TIMES A DAY. THE PATIENT REPORTED SOMETIME AFTER THE ALLEGED ISSUE OCCURRED HE DEVELOPED SYMPTOMS OF ¿BLURRED VISION AND TIRED¿ WHICH HE ASSOCIATED WITH HYPOGLYCEMIA. THE PATIENT REPORTED DURING THE WEEK PRIOR TO CONTACTING LFS, A READING OF ¿44.0MMOL/L¿ WAS OBTAINED ON A HOSPITAL METER AND HE WAS TREATED IN THE HOSPITAL WITH IV FLUIDS AND INSULIN DRIP AND STAYED 1 WEEK. AT THE TIME OF TROUBLESHOOTING, THE CCA WAS UNABLE TO RESOLVE THE ALLEGED ISSUE AND CONFIRMED IT WAS NOT THE FIRST TIME THE METER HAD BEEN USED. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE, THE PATIENT CLAIMS DUE TO THE ALLEGED ISSUE, HE GAVE HIMSELF TOO MUCH MEDICATION, SUFFERED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AND REQUIRED TREATMENT FROM A HEALTHCARE PROFESSIONAL.