Description of Event or Problem · 1
ON (B)(6) 2013 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) IN (B)(4) ALLEGING HER ONETOUCH ULTRA EASY METER WAS DISPLAYING AN ERROR 2 MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT COULD NOT RECALL WHEN THE ALLEGED ISSUE BEGAN. SHE REPORTEDLY MANAGES HER DIABETES WITH METFORMIN PILLS, NOVORAPID INSULIN AFTER MEALS AND LANTUS INSULIN AT BEDTIME AND REPORTED THAT ON THE SAME DAY THE AFTER THE ISSUE OCCURRED SHE ADMINISTERED HER NORMAL DOSE OF 24 UNITS OF NOVORAPID INSULIN. AT AN UNKNOWN TIME AFTER THE ALLEGED ISSUE OCCURRED, SHE REPORTED THAT SHE DEVELOPED SYMPTOMS OF ¿FEELING UNWELL, SHAKY, NERVOUS AND FELT TO BE LOSING CONSCIOUSNESS.¿ AFTER 5-10 MINUTES LATER, SHE SELF-TREATED HER SYMPTOMS BY EATING A BREAD ROLL AND FELT BETTER IMMEDIATELY AFTERWARDS. NO OTHER DEVICE WAS USED FOR TESTING. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT DEVICE WAS NOT BEING USED FOR THE FIRST TIME. THE SUBJECT TEST STRIPS WERE IN GOOD CONDITION AND THE TESTING TECHNIQUE WAS CORRECT. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT AND SUBJECT PRODUCTS ARE PENDING RETURN FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.