Description of Event or Problem · 1
ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING HIS OT VERIO PRO 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 THE DAY PRIOR TO CONTACTING LFS FOR ASSISTANCE AT APPROXIMATELY 4:07PM. HE TESTED BACK TO BACK ON THE SUBJECT DEVICE AND OBSERVED VALUES OF ¿335 MG/DL AND 275MG/DL¿ PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. THE PATIENT REPORTEDLY MANAGES HIS DIABETES WITH INSULIN AND IS A SELF ADJUSTER AND HE DENIED MAKING ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT DENIED DEVELOPING ANY SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE AND STATED HE SELF TREATED WITH 8 UNITS OF NOVORAPID INSULIN AT APPROXIMATELY 4:10PM THAT SAME DAY. NO OTHER FORM OF TREATMENT WAS ADMINISTERED. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE SUBJECT METER IS NOT BEING USED FOR THE FIRST TIME. THE UNIT OF MEASURE WAS SET CORRECTLY AT THE TIME. THE SAMPLES WERE TAKEN FROM THE SAME APPROVED SAMPLE SITE. THE SUBJECT TEST STRIPS WERE REPORTEDLY IN GOOD CONDITION, UNEXPIRED AND STORED CORRECTLY. THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION AVAILABLE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT AND SUBJECT PRODUCTS ARE PENDING RETURN FOR INVESTIGATION. THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THE PATIENT DID NOT SUFFER FROM ANY SERIOUS INJURIES AND DID NOT ADMINISTER INAPPROPRIATE SELF TREATMENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE, THE METER DID NOT MEET LFS¿S CRITERIA FOR ACCURACY.