Description of Event or Problem · 1
ON (B)(6) 2013, THE LAY USER/REPORTER CONTACTED LIFESCAN (LFS) ALLEGING HER SON'S ONETOUCH ULTRALINK METER WAS DISPLAYING AN INACCURATELY HIGH RESULT COMPARED TO HIS FEELINGS OR NORMAL RESULTS. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO FOLLOW UP WITH THE PATIENT FOR ADDITIONAL INFORMATION. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE REPORTER STATED BETWEEN (B)(6) (UNKNOWN YEAR) THE PATIENT OBTAINED READINGS OF "100, 70, 50, 300 AND 300MG/DL." IT IS UNCLEAR HOW MUCH TIME PASSED IN BETWEEN THE READINGS. THE REPORTER STATED THE PATIENT HAD LESS FOOD THAN USUAL ON (B)(6) 2013 IN THE MORNING. THE REPORTER STATED SOME TIME LATER THE PATIENT DEVELOPED SYMPTOMS OF "UNCONSCIOUS AND CONVULSIONS." THE REPORTER STATED ON (B)(6) 2013 AT 11AM UNKNOWN READINGS WERE OBTAINED ON AN ER OR HOSPITAL METER, AND THE PATIENT WAS GIVEN INSULIN AS TREATMENT. IT IS UNCLEAR IF THE PATIENT WAS TREATED FOR AN ACUTE COMPLICATION OF DIABETES OR ANOTHER DIAGNOSIS. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE SUBJECT METER WAS IN THE CORRECT UNIT OF MEASUREMENT AT THE TIME OF TESTING AND THE PATIENT'S TEST STRIPS WERE IN GOOD CONDITION. HOWEVER A CONTROL SOLUTION TEST WAS NOT RUN DUE TO THE PATIENT NOT HAVING ANY CONTROL SOLUTION AT THE TIME OF THE CALL. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT AND THE PRODUCTS WERE REQUESTED FOR RETURN. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE REPORTER CLAIMS, DUE TO THE ALLEGED ISSUE, THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE OF AN ACUTE COMPLICATION OF DIABETES AND REQUIRED TREATMENT FROM A HEALTH CARE PROFESSIONAL.