Description of Event or Problem · 1
ON (B)(6) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ((B)(6)) ALLEGING THAT HER ONETOUCH ULTRASMART METER WAS READING INACCURATELY HIGH. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN ON (B)(6) 2014 AT AN UNKNOWN TIME IN THE AFTERNOON. THE PATIENT WAS ON HER WALK WHEN SHE BEGAN FEELING "SHAKY AND DISQUIETNESS/UNEASY." APPROXIMATELY 15 MINUTES LATER, SHE TESTED ON THE SUBJECT METER AND OBSERVED A READING OF "95MG/DL." THE PATIENT MANAGES HER DIABETES WITH AN UNKNOWN TYPE/DOSE OF INSULIN THROUGH PUMP THERAPY AND DID NOT MAKE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED ISSUE. APPROXIMATELY 20 MINUTES LATER, THE PATIENT TESTED ON HER BACK UP METER (ACCUCHEK) AND OBSERVED A READING OF "49MG/DL." BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <=30% AND/ OR <=30 MG/DL. THE PATIENT SELF-TREATED IMMEDIATELY WITH GLUCOSE TABLETS AND FELT BETTER WITHIN 45 MINUTES. AT THE TIME OF TROUBLESHOOTING THE CCA CONFIRMED THE METER WAS SET TO THE CORRECT UNIT OF MEASURE, THE SAMPLES WERE OBTAINED FROM THE SAME APPROVED SAMPLE SITE. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT AND SUBJECT PRODUCTS ARE PENDING RETURN FOR INVESTIGATION. THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT¿S SYMPTOMS STARTED BEFORE THE REPORTED ISSUE FIRST OCCURRED AND THERE IS NO EVIDENCE THE PATIENT ADMINISTERED INAPPROPRIATE SELF-TREATMENT DUE TO THE ALLEGED ISSUE. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE SUBJECT DEVICE DID NOT MEET LFS SPECIFICATIONS FOR ACCURACY.