Description of Event or Problem · 1
ON (B)(6) 2013, A REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) GERMANY ALLEGING THE PATIENT'S ONETOUCH VITA ENHANCED METER READ INACCURATELY COMPARED TO ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON THE EVENING OF (B)(6) 2013. IT WAS REPORTED, THE PATIENT OBTAINED BLOOD GLUCOSE RESULTS OF "104 MG/DL" WITH THE SUBJECT METER AND "115 MG/DL" ON ANOTHER METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS DO NOT EXCEED THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. THE PATIENT DOES NOT TAKE MEDICATIONS TO MANAGE HIS DIABETES; HOWEVER, IN THE EVENING, THE PATIENT REPORTEDLY EXERCISED. THAT SAME EVENING, THE REPORTER CLAIMS THE PATIENT FELT SYMPTOMS OF UNREST, SWEATING AND COLD HANDS. THE PATIENT ATE FOOD AND/ OR DRANK A BEVERAGE AS TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING. CONTROL SOLUTION WAS SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.